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Company

AstraZeneca

Pharmaceutical intelligence for AstraZeneca with 201 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

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Recent signals(81)

RegulatoryAugust 5, 2026

FDA Accepts Supplemental NDA for Brilinta (Ticagrelor) by AstraZeneca

The FDA has accepted a supplemental NDA for Brilinta (ticagrelor) submitted by AstraZeneca.

RegulatoryAugust 1, 2026

Datroway Approved in EU for Metastatic TNBC as First TROP2-Directed Therapy

Datroway has been approved in the EU as the only TROP2-directed therapy demonstrating overall survival benefit for first-line treatment in metastatic TNBC patients not eligible for immunotherapy.

RegulatoryJuly 31, 2026

FDA Acceptance of Supplemental NDA for CRESTOR by AstraZeneca

The FDA has accepted a supplemental NDA for CRESTOR (rosuvastatin calcium) submitted by AstraZeneca.

RegulatoryJuly 31, 2026

FDA Submission Update for Breztri Aerosphere by AstraZeneca

AstraZeneca's Breztri Aerosphere (NDA212122) has a submission status of Approved (AP) with a standard review priority.

RegulatoryJuly 31, 2026

FDA Acceptance of SYMBICORT AEROSPHERE Supplement by AstraZeneca

The FDA has accepted the supplemental NDA for SYMBICORT AEROSPHERE, indicating a step forward in its regulatory process.

ClinicalJuly 30, 2026

Phase Ib/II Trial of Olaparib with AZD2014 or AZD5363 in Recurrent Endometrial and Ovarian Cancer

This trial evaluates the safety and optimal dosing of olaparib in combination with either vistusertib or capivasertib for recurrent cancers.

RegulatoryJuly 29, 2026

FDA Accepts Application for SAPHNELO (Anifrolimab-FNIA) by AstraZeneca

The FDA has accepted the Biologics License Application for SAPHNELO (anifrolimab-FNIA) submitted by AstraZeneca.

ClinicalJuly 29, 2026

AstraZeneca's Study on AZD6234 and AZD9550 Impact on Oral Contraceptive Pharmacokinetics

AstraZeneca is conducting a study to evaluate the pharmacokinetics of ethinyl estradiol/levonorgestrel when administered with AZD6234 and AZD9550.

CompetitiveJuly 29, 2026

AstraZeneca's GEMINI-PeriOp GC Study Targets Locally Advanced Gastroesophageal Adenocarcinoma

AstraZeneca's GEMINI-PeriOp GC study is evaluating novel agents or combinations for perioperative treatment in patients with locally advanced resectable gastroesophageal adenocarcinoma.

ClinicalJuly 28, 2026

Ultomiris Phase III trial fails to meet primary endpoint in HSCT-TMA

Ultomiris did not achieve statistical significance for event-free survival in HSCT-TMA patients compared to placebo.

ClinicalJuly 28, 2026

Sonesitatug vedotin shows significant survival benefit in advanced gastric cancers

Sonesitatug vedotin demonstrated a statistically significant improvement in overall survival for patients with CLDN18.2-positive advanced gastric/GEJ cancers.

RegulatoryJuly 26, 2026

AstraZeneca's EPLONTERSEN SODIUM Autoinjector Receives AP Status from FDA

The FDA has granted an Approval Pending (AP) status for AstraZeneca's autoinjector application for EPLONTERSEN SODIUM.

ClinicalJuly 26, 2026

AstraZeneca initiates post-marketing surveillance for Lynparza in South Korea

AstraZeneca is conducting a post-marketing surveillance study to evaluate the safety and effectiveness of Lynparza in real-world settings in South Korea.

CompetitiveJuly 25, 2026

AstraZeneca Initiates Phase 1b/2 Trial of AZD0120 for Relapsed/Refractory Multiple Myeloma

AstraZeneca is conducting Phase 1b/2 trial of AZD0120, a dual CAR T-cell therapy targeting CD19 and BCMA, in patients with relapsed/refractory multiple myeloma.

RegulatoryJuly 24, 2026

Etcamah Approved in EU for 1st-Line Advanced ER+ Breast Cancer

Etcamah (camizestrant) has been approved in the EU for use in combination with CDK4/6 inhibitors for 1st-line advanced ER-positive breast cancer, based on SERENA-6 trial results.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for QTERN (Dapagliflozin/Saxagliptin)

The FDA has approved a supplemental application for QTERN, a combination of dapagliflozin and saxagliptin.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for Farxiga (Dapagliflozin)

The FDA has approved a supplemental application for Farxiga, an SGLT2 inhibitor developed by AstraZeneca.

ClinicalJuly 21, 2026

AstraZeneca Launches AI Study for Lung Cancer Risk Stratification

AstraZeneca is conducting an observational study to evaluate AI's role in detecting pulmonary nodules and predicting lung cancer risk in high-risk individuals.

ClinicalJuly 21, 2026

AstraZeneca Initiates Phase I/II Study of AZD4512 in B-cell Non-Hodgkin Lymphoma

AstraZeneca is conducting Phase I/II study to assess AZD4512 as monotherapy or in combination with other agents for relapsed/refractory B-NHL.

RegulatoryJuly 21, 2026

FDA Accepts Supplement for IMFINZI (Durvalumab) by AstraZeneca

The FDA has accepted a supplemental application for IMFINZI (Durvalumab) from AstraZeneca.

RegulatoryJuly 20, 2026

AstraZeneca's Capivasertib NDA218197 Receives AP Status from FDA

The FDA has granted AstraZeneca's NDA218197 for Capivasertib an Approval Pending (AP) status.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental Application for KOSELUGO (Selumetinib)

The FDA has accepted a supplemental application for KOSELUGO (selumetinib) submitted by AstraZeneca.

ClinicalJuly 18, 2026

AstraZeneca's AZD4954 Study Evaluates Safety and Pharmacokinetics in Healthy Adults

AstraZeneca is conducting a study to assess the safety, tolerability, PK, and PD of AZD4954 in healthy adults, including those with elevated Lp(a) levels.

ClinicalJuly 18, 2026

AstraZeneca's AZD0120 Phase I Study in Multiple Myeloma Initiated

AstraZeneca has initiated Phase I study to evaluate the safety and tolerability of AZD0120 in multiple myeloma patients.

RegulatoryJuly 18, 2026

FDA Approves BAXFENDY (BAXDROSTAT) by AstraZeneca

The FDA has approved BAXFENDY (BAXDROSTAT) under NDA219878, indicating a significant milestone for AstraZeneca.

ClinicalJuly 18, 2026

AstraZeneca's Study on Durvalumab and Tremelimumab in HCC with TACE

AstraZeneca is conducting a global study evaluating the combination of durvalumab, tremelimumab, and lenvatinib with TACE in patients with locoregional hepatocellular carcinoma.

ClinicalJuly 17, 2026

AstraZeneca's AZD5004 Study Evaluates Drug Interaction with Mitiglinide and Pioglitazone

AstraZeneca is conducting a study to assess the pharmacokinetics of mitiglinide and pioglitazone when administered with AZD5004.

ClinicalJuly 17, 2026

AstraZeneca's Study on MET Concordance in Treatment-Naïve NSCLC

AstraZeneca is conducting a multicenter study to assess MET concordance and gene profiling in treatment-naïve non-small cell lung cancer (NSCLC).

RegulatoryJuly 16, 2026

FDA Accepts Supplemental Application for Fasenra (Benralizumab) by AstraZeneca

The FDA has accepted a supplemental application for Fasenra (benralizumab) from AstraZeneca.

ClinicalJuly 14, 2026

AstraZeneca's Dapagliflozin Approved for Heart Failure; Real-World Study Launched in Germany

Dapagliflozin has been approved by the European Commission for heart failure treatment, applicable to all patients regardless of ejection fraction or diabetes status.

StrategyJuly 14, 2026

AstraZeneca licenses novel EGFR inhibitor Zegfrovy for lung cancer

AstraZeneca has secured an exclusive global license for Zegfrovy, an oral EGFR inhibitor for lung cancer.

RegulatoryJuly 13, 2026

FDA Approves Supplemental Application for BRILINTA (Ticagrelor)

The FDA has approved a supplemental application for BRILINTA, a medication containing ticagrelor, submitted by AstraZeneca.

ClinicalJuly 13, 2026

AstraZeneca's Rilvegostomig Study Targets Advanced Solid Tumors with Subcutaneous Administration

AstraZeneca is investigating the pharmacokinetics and safety of subcutaneous rilvegostomig in adults with advanced solid tumors.

ClinicalJuly 10, 2026

AstraZeneca Evaluates Surovatamig for CLL/SLL Consolidation Therapy

AstraZeneca is conducting a trial to assess the safety and efficacy of Surovatamig as consolidation therapy in CLL/SLL patients with unmutated IGHV.

ClinicalJuly 9, 2026

AstraZeneca's Wainua fails primary endpoint in ATTR-CM Phase III trial

The CARDIO-TTRansform Phase III trial for Wainua (eplontersen) did not meet its primary efficacy endpoint.

ClinicalJuly 9, 2026

AstraZeneca's Anifrolumab Study for Systemic Lupus Erythematosus Underway

AstraZeneca is conducting a study to evaluate the pharmacokinetics, pharmacodynamics, and safety of anifrolumab in patients with systemic lupus erythematosus.

ClinicalJuly 8, 2026

AstraZeneca Investigates Safety of Ondexxya IV Injection in Real-World Use

AstraZeneca is conducting a survey to assess the safety and effectiveness of Ondexxya IV Injection 200 mg in real-world conditions.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for CRESTOR (Rosuvastatin Calcium)

The FDA has approved a supplemental application for CRESTOR, a statin medication.

ClinicalJuly 7, 2026

AstraZeneca's Phase III Trial of Baxdrostat in Primary Aldosteronism Underway

AstraZeneca is conducting Phase III trial to evaluate the efficacy and safety of baxdrostat in patients with Primary Aldosteronism.

RegulatoryJuly 6, 2026

FDA Approves Supplemental Application for Breztri Aerosphere

The FDA has approved a supplemental application for Breztri Aerosphere, containing budesonide, formoterol fumarate, and glycopyrrolate.

RegulatoryJuly 6, 2026

FDA Accepts Supplemental Application for SYMBICORT AEROSPHERE

The FDA has accepted a supplemental application for SYMBICORT AEROSPHERE, indicating progress in its regulatory review.

RegulatoryJuly 6, 2026

FDA Accepts BLA for Anifrolumab by AstraZeneca

The FDA has accepted the Biologics License Application for Anifrolumab, a treatment for systemic lupus erythematosus.

ClinicalJuly 5, 2026

AstraZeneca initiates Phase I/II trial of AZD9829 for CD123+ hematological malignancies

AstraZeneca is conducting Phase I/II trial to evaluate AZD9829 in patients with CD123+ hematological malignancies.

ClinicalJuly 4, 2026

AstraZeneca's PT010 Study Targets Severe Asthma in Adults and Adolescents

AstraZeneca is conducting a study to evaluate the efficacy and safety of PT010, a combination inhaler, in patients with inadequately controlled severe asthma.

RegulatoryJuly 3, 2026

FDA Accepts Supplemental Application for WAINUA Autoinjector by AstraZeneca

The FDA has accepted a supplemental application for the WAINUA autoinjector containing EPLONTERSEN SODIUM.

RegulatoryJune 30, 2026

Enhertu Secures EU Approval as First Tumour Agnostic HER2 Therapy

Enhertu has been approved in the EU as the first tumour agnostic HER2-directed therapy for previously treated HER2-positive metastatic solid tumours.

RegulatoryJune 29, 2026

Datroway recommended for EU approval as 1st-line treatment for TNBC

Datroway has been recommended for approval in the EU as a 1st-line treatment for metastatic triple-negative breast cancer.

ClinicalJune 28, 2026

Durvalumab and Cetuximab Combination Trial for Head and Neck Cancer

A clinical trial is underway to evaluate the efficacy of durvalumab combined with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma.

ClinicalJune 27, 2026

Trial Compares Rivaroxaban and Ticagrelor Against Clopidogrel for Stroke Prevention

The trial aims to assess if rivaroxaban or ticagrelor, alone or in combination, is more effective than clopidogrel in reducing ischemic stroke and related outcomes.

ClinicalJune 26, 2026

AstraZeneca initiates Phase 3 extension study for Tozorakimab in COPD patients

AstraZeneca is conducting Phase 3 extension study to evaluate the long-term efficacy and safety of Tozorakimab in COPD patients with a history of exacerbations.

ClinicalJune 26, 2026

AstraZeneca's Elecoglipron Phase III Trials Target Obesity and T2DM

AstraZeneca is conducting two pivotal Phase III studies to evaluate the efficacy and safety of elecoglipron in adults with obesity or overweight, with and without T2DM.

ClinicalJune 24, 2026

Phase III Trial of Durvalumab Post-Surgery in Early-Stage NSCLC Shows Potential Benefit

The INSIGHT trial is comparing durvalumab to standard observation in patients with early-stage non-small cell lung cancer post-surgery.

RegulatoryJune 23, 2026

AstraZeneca's Capivasertib Receives AP Status from FDA

The FDA has granted AstraZeneca's NDA218197 for Capivasertib an Approval Pending (AP) status.

ClinicalJune 23, 2026

Phase Ⅲ Trial of Rilvegostomig in HER2-positive Gastric Cancer Initiated by AstraZeneca

AstraZeneca is conducting Phase Ⅲ trial to evaluate rilvegostomig combined with fluoropyrimidine and T-DXd in HER2-positive gastric cancer.

RegulatoryJune 22, 2026

FDA approves capivasertib with abiraterone for PTEN-deficient prostate cancer

Capivasertib has been approved by the FDA for use with abiraterone and prednisone in treating PTEN-deficient metastatic prostate cancer.

ClinicalJune 19, 2026

Pentoxifylline and α-Tocopherol Study for RILI in Stage III NSCLC Patients

A clinical trial is investigating the efficacy of Pentoxifylline and α-Tocopherol in preventing radiation-induced lung injury in stage III NSCLC patients.

CompetitiveJune 19, 2026

AstraZeneca Leads Study on DLBCL Treatment Patterns in MEA Region

AstraZeneca is sponsoring a multicenter observational study to analyze treatment patterns and access to novel therapies for DLBCL patients in the MEA region.

RegulatoryJune 18, 2026

FDA Acceptance of NDA for Capivasertib by AstraZeneca

The FDA has accepted the NDA for Capivasertib, indicating progress in its regulatory review.

ClinicalJune 18, 2026

Phase II Trial of Olaparib and Durvalumab Combinations in Recurrent Endometrial Cancer

A phase II trial is evaluating the efficacy of combinations of olaparib, durvalumab, cediranib, and capivasertib in recurrent or refractory endometrial cancer.

ClinicalJune 18, 2026

Phase II Trial of Selumetinib and Olaparib in RAS Pathway Mutant Ovarian and Endometrial Cancers

A phase II trial is comparing the efficacy of selumetinib plus olaparib versus selumetinib alone in patients with RAS pathway mutant recurrent or persistent ovarian and endometrial cancers.

RegulatoryJune 18, 2026

FDA Accepts Application for BAXFENDY (BAXDROSTAT) from AstraZeneca

The FDA has accepted the New Drug Application for BAXFENDY (BAXDROSTAT) from AstraZeneca.

ClinicalJune 18, 2026

EVOLVE Study to Assess Real-World Effectiveness of Tezepelumab in Severe Asthma in Greece

The EVOLVE study will evaluate the real-world effectiveness of tezepelumab in uncontrolled severe asthma over two years in Greece.

ClinicalJune 17, 2026

Study on Durvalumab, Bevacizumab, and TACE for Advanced Hepatocellular Carcinoma

A clinical trial is evaluating the combination of durvalumab, bevacizumab, and TACE for advanced HCC, focusing on 6-month progression-free survival.

ClinicalJune 17, 2026

Phase III Trial of MEDI5752 in Unresectable Pleural Mesothelioma Launched

A phase III trial is underway to evaluate the efficacy and safety of MEDI5752 in combination with standard chemotherapy in patients with unresectable pleural mesothelioma.

ClinicalJune 17, 2026

Phase III Study of Durvalumab + Domvanalimab in Stage III Unresectable NSCLC Initiated

A Phase III trial is underway to evaluate the combination of durvalumab and domvanalimab in patients with unresectable NSCLC.

ClinicalJune 17, 2026

Phase III Trial of Osimertinib and Bevacizumab in EGFR-Mutant Lung Cancer

A phase III trial is comparing osimertinib alone versus its combination with bevacizumab in patients with EGFR-mutant non-small cell lung cancer.

ClinicalJune 17, 2026

Phase III Trial of Durvalumab with Chemotherapy in Stage II-III Breast Cancer

A phase III trial is evaluating the addition of durvalumab to standard chemotherapy in patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

ClinicalJune 17, 2026

Phase III Trial Evaluates Hormone Therapy and Chemotherapy in Invasive Breast Cancer

A randomized phase III trial is assessing the efficacy of tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy in invasive breast cancer.

RegulatoryJune 16, 2026

FDA ODAC Vote Against Camizestrant for HR-Positive Breast Cancer Raises Concerns

The FDA's ODAC did not reach a majority vote in favor of camizestrant's benefit-risk profile for advanced HR-positive breast cancer.

StrategyJune 16, 2026

AstraZeneca Reports Strong Q1 2026 Revenue Growth and Positive NME Readouts

AstraZeneca reported a 13% increase in total revenue for Q1 2026, driven by strong product sales and positive readouts from new molecular entities (NMEs).

RegulatoryJune 16, 2026

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

RegulatoryJune 16, 2026

FDA Extends Decision Date for AstraZeneca's Camizestrant in HR-positive Breast Cancer

The FDA has extended the PDUFA date for camizestrant to allow for additional data review related to its NDA.

RegulatoryJune 16, 2026

Truqap approved in US for PTEN-deficient metastatic prostate cancer

Truqap, a first-in-class AKT inhibitor, has been approved in the US for treating PTEN-deficient metastatic hormone-sensitive prostate cancer.

RegulatoryJune 16, 2026

Imfinzi Gains US Approval for Early Bladder Cancer with BCG Combination

Imfinzi has been approved in the US as the first immunotherapy combination for BCG-naïve, high-risk non-muscle-invasive bladder cancer, showing a 32% reduction in disease recurrence, progression, or death.

RegulatoryJune 16, 2026

Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications

Enhertu has received FDA approval for two new indications in HER2-positive early breast cancer, both before and after surgery.

RegulatoryJune 16, 2026

FDA ODAC Recommends Truqap for PTEN-Deficient Prostate Cancer

The FDA ODAC has recommended Truqap in combination with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer.

RegulatoryJune 16, 2026

Datroway approved in US as first TROP2-directed ADC for 1L triple-negative breast cancer

Datroway is approved in the US as the first TROP2-directed antibody drug conjugate for 1st-line treatment of metastatic triple-negative breast cancer.

ClinicalJune 16, 2026

Imfinzi + EV shows significant survival benefits in muscle-invasive bladder cancer

The Phase III VOLGA trial demonstrated that perioperative Imfinzi plus neoadjuvant EV significantly improves event-free survival and shows a favorable trend in overall survival for muscle-invasive bladder cancer.

RegulatoryJune 16, 2026

Camizestrant Recommended for 1st-Line ER-Positive Breast Cancer in EU

Camizestrant, in combination with CDK4/6 inhibitor, has been recommended for approval in the EU for 1st-line advanced ER-positive breast cancer based on SERENA-6 trial results.

ClinicalJune 16, 2026

Tozorakimab Shows Positive Phase III Results in COPD, Reducing Exacerbations

Tozorakimab met its primary endpoint in the Phase III MIRANDA trial, showing significant reduction in COPD exacerbations.

ClinicalJune 16, 2026

Ultomiris meets primary endpoint in Phase III trial for IgAN

Ultomiris showed a statistically significant reduction of proteinuria in adults with immunoglobulin A nephropathy in the Phase III I CAN trial.

Upcoming catalysts(1)

Phase III Readout

AstraZeneca — Imfinzi

Positive data would strengthen AZ IO portfolio against Merck dominance in thoracic oncology.

October 12, 2026 · Phase III

Regulatory activity(36)

RegulatoryAugust 5, 2026

FDA Accepts Supplemental NDA for Brilinta (Ticagrelor) by AstraZeneca

The FDA has accepted a supplemental NDA for Brilinta (ticagrelor) submitted by AstraZeneca.

RegulatoryAugust 1, 2026

Datroway Approved in EU for Metastatic TNBC as First TROP2-Directed Therapy

Datroway has been approved in the EU as the only TROP2-directed therapy demonstrating overall survival benefit for first-line treatment in metastatic TNBC patients not eligible for immunotherapy.

RegulatoryJuly 31, 2026

FDA Acceptance of Supplemental NDA for CRESTOR by AstraZeneca

The FDA has accepted a supplemental NDA for CRESTOR (rosuvastatin calcium) submitted by AstraZeneca.

RegulatoryJuly 31, 2026

FDA Submission Update for Breztri Aerosphere by AstraZeneca

AstraZeneca's Breztri Aerosphere (NDA212122) has a submission status of Approved (AP) with a standard review priority.

RegulatoryJuly 31, 2026

FDA Acceptance of SYMBICORT AEROSPHERE Supplement by AstraZeneca

The FDA has accepted the supplemental NDA for SYMBICORT AEROSPHERE, indicating a step forward in its regulatory process.

RegulatoryJuly 29, 2026

FDA Accepts Application for SAPHNELO (Anifrolimab-FNIA) by AstraZeneca

The FDA has accepted the Biologics License Application for SAPHNELO (anifrolimab-FNIA) submitted by AstraZeneca.

RegulatoryJuly 26, 2026

AstraZeneca's EPLONTERSEN SODIUM Autoinjector Receives AP Status from FDA

The FDA has granted an Approval Pending (AP) status for AstraZeneca's autoinjector application for EPLONTERSEN SODIUM.

RegulatoryJuly 24, 2026

Etcamah Approved in EU for 1st-Line Advanced ER+ Breast Cancer

Etcamah (camizestrant) has been approved in the EU for use in combination with CDK4/6 inhibitors for 1st-line advanced ER-positive breast cancer, based on SERENA-6 trial results.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for QTERN (Dapagliflozin/Saxagliptin)

The FDA has approved a supplemental application for QTERN, a combination of dapagliflozin and saxagliptin.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for Farxiga (Dapagliflozin)

The FDA has approved a supplemental application for Farxiga, an SGLT2 inhibitor developed by AstraZeneca.

RegulatoryJuly 21, 2026

FDA Accepts Supplement for IMFINZI (Durvalumab) by AstraZeneca

The FDA has accepted a supplemental application for IMFINZI (Durvalumab) from AstraZeneca.

RegulatoryJuly 20, 2026

AstraZeneca's Capivasertib NDA218197 Receives AP Status from FDA

The FDA has granted AstraZeneca's NDA218197 for Capivasertib an Approval Pending (AP) status.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental Application for KOSELUGO (Selumetinib)

The FDA has accepted a supplemental application for KOSELUGO (selumetinib) submitted by AstraZeneca.

RegulatoryJuly 18, 2026

FDA Approves BAXFENDY (BAXDROSTAT) by AstraZeneca

The FDA has approved BAXFENDY (BAXDROSTAT) under NDA219878, indicating a significant milestone for AstraZeneca.

RegulatoryJuly 16, 2026

FDA Accepts Supplemental Application for Fasenra (Benralizumab) by AstraZeneca

The FDA has accepted a supplemental application for Fasenra (benralizumab) from AstraZeneca.

RegulatoryJuly 13, 2026

FDA Approves Supplemental Application for BRILINTA (Ticagrelor)

The FDA has approved a supplemental application for BRILINTA, a medication containing ticagrelor, submitted by AstraZeneca.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for CRESTOR (Rosuvastatin Calcium)

The FDA has approved a supplemental application for CRESTOR, a statin medication.

RegulatoryJuly 6, 2026

FDA Approves Supplemental Application for Breztri Aerosphere

The FDA has approved a supplemental application for Breztri Aerosphere, containing budesonide, formoterol fumarate, and glycopyrrolate.

RegulatoryJuly 6, 2026

FDA Accepts Supplemental Application for SYMBICORT AEROSPHERE

The FDA has accepted a supplemental application for SYMBICORT AEROSPHERE, indicating progress in its regulatory review.

RegulatoryJuly 6, 2026

FDA Accepts BLA for Anifrolumab by AstraZeneca

The FDA has accepted the Biologics License Application for Anifrolumab, a treatment for systemic lupus erythematosus.

RegulatoryJuly 3, 2026

FDA Accepts Supplemental Application for WAINUA Autoinjector by AstraZeneca

The FDA has accepted a supplemental application for the WAINUA autoinjector containing EPLONTERSEN SODIUM.

RegulatoryJune 30, 2026

Enhertu Secures EU Approval as First Tumour Agnostic HER2 Therapy

Enhertu has been approved in the EU as the first tumour agnostic HER2-directed therapy for previously treated HER2-positive metastatic solid tumours.

RegulatoryJune 29, 2026

Datroway recommended for EU approval as 1st-line treatment for TNBC

Datroway has been recommended for approval in the EU as a 1st-line treatment for metastatic triple-negative breast cancer.

RegulatoryJune 23, 2026

AstraZeneca's Capivasertib Receives AP Status from FDA

The FDA has granted AstraZeneca's NDA218197 for Capivasertib an Approval Pending (AP) status.

RegulatoryJune 22, 2026

FDA approves capivasertib with abiraterone for PTEN-deficient prostate cancer

Capivasertib has been approved by the FDA for use with abiraterone and prednisone in treating PTEN-deficient metastatic prostate cancer.

RegulatoryJune 18, 2026

FDA Acceptance of NDA for Capivasertib by AstraZeneca

The FDA has accepted the NDA for Capivasertib, indicating progress in its regulatory review.

RegulatoryJune 18, 2026

FDA Accepts Application for BAXFENDY (BAXDROSTAT) from AstraZeneca

The FDA has accepted the New Drug Application for BAXFENDY (BAXDROSTAT) from AstraZeneca.

RegulatoryJune 16, 2026

FDA ODAC Vote Against Camizestrant for HR-Positive Breast Cancer Raises Concerns

The FDA's ODAC did not reach a majority vote in favor of camizestrant's benefit-risk profile for advanced HR-positive breast cancer.

RegulatoryJune 16, 2026

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

RegulatoryJune 16, 2026

FDA Extends Decision Date for AstraZeneca's Camizestrant in HR-positive Breast Cancer

The FDA has extended the PDUFA date for camizestrant to allow for additional data review related to its NDA.

RegulatoryJune 16, 2026

Truqap approved in US for PTEN-deficient metastatic prostate cancer

Truqap, a first-in-class AKT inhibitor, has been approved in the US for treating PTEN-deficient metastatic hormone-sensitive prostate cancer.

RegulatoryJune 16, 2026

Imfinzi Gains US Approval for Early Bladder Cancer with BCG Combination

Imfinzi has been approved in the US as the first immunotherapy combination for BCG-naïve, high-risk non-muscle-invasive bladder cancer, showing a 32% reduction in disease recurrence, progression, or death.

RegulatoryJune 16, 2026

Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications

Enhertu has received FDA approval for two new indications in HER2-positive early breast cancer, both before and after surgery.

RegulatoryJune 16, 2026

FDA ODAC Recommends Truqap for PTEN-Deficient Prostate Cancer

The FDA ODAC has recommended Truqap in combination with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer.

RegulatoryJune 16, 2026

Datroway approved in US as first TROP2-directed ADC for 1L triple-negative breast cancer

Datroway is approved in the US as the first TROP2-directed antibody drug conjugate for 1st-line treatment of metastatic triple-negative breast cancer.

RegulatoryJune 16, 2026

Camizestrant Recommended for 1st-Line ER-Positive Breast Cancer in EU

Camizestrant, in combination with CDK4/6 inhibitor, has been recommended for approval in the EU for 1st-line advanced ER-positive breast cancer based on SERENA-6 trial results.

Clinical activity(40)

ClinicalJuly 30, 2026

Phase Ib/II Trial of Olaparib with AZD2014 or AZD5363 in Recurrent Endometrial and Ovarian Cancer

This trial evaluates the safety and optimal dosing of olaparib in combination with either vistusertib or capivasertib for recurrent cancers.

ClinicalJuly 29, 2026

AstraZeneca's Study on AZD6234 and AZD9550 Impact on Oral Contraceptive Pharmacokinetics

AstraZeneca is conducting a study to evaluate the pharmacokinetics of ethinyl estradiol/levonorgestrel when administered with AZD6234 and AZD9550.

ClinicalJuly 28, 2026

Ultomiris Phase III trial fails to meet primary endpoint in HSCT-TMA

Ultomiris did not achieve statistical significance for event-free survival in HSCT-TMA patients compared to placebo.

ClinicalJuly 28, 2026

Sonesitatug vedotin shows significant survival benefit in advanced gastric cancers

Sonesitatug vedotin demonstrated a statistically significant improvement in overall survival for patients with CLDN18.2-positive advanced gastric/GEJ cancers.

ClinicalJuly 26, 2026

AstraZeneca initiates post-marketing surveillance for Lynparza in South Korea

AstraZeneca is conducting a post-marketing surveillance study to evaluate the safety and effectiveness of Lynparza in real-world settings in South Korea.

ClinicalJuly 21, 2026

AstraZeneca Launches AI Study for Lung Cancer Risk Stratification

AstraZeneca is conducting an observational study to evaluate AI's role in detecting pulmonary nodules and predicting lung cancer risk in high-risk individuals.

ClinicalJuly 21, 2026

AstraZeneca Initiates Phase I/II Study of AZD4512 in B-cell Non-Hodgkin Lymphoma

AstraZeneca is conducting Phase I/II study to assess AZD4512 as monotherapy or in combination with other agents for relapsed/refractory B-NHL.

ClinicalJuly 18, 2026

AstraZeneca's AZD4954 Study Evaluates Safety and Pharmacokinetics in Healthy Adults

AstraZeneca is conducting a study to assess the safety, tolerability, PK, and PD of AZD4954 in healthy adults, including those with elevated Lp(a) levels.

ClinicalJuly 18, 2026

AstraZeneca's AZD0120 Phase I Study in Multiple Myeloma Initiated

AstraZeneca has initiated Phase I study to evaluate the safety and tolerability of AZD0120 in multiple myeloma patients.

ClinicalJuly 18, 2026

AstraZeneca's Study on Durvalumab and Tremelimumab in HCC with TACE

AstraZeneca is conducting a global study evaluating the combination of durvalumab, tremelimumab, and lenvatinib with TACE in patients with locoregional hepatocellular carcinoma.

ClinicalJuly 17, 2026

AstraZeneca's AZD5004 Study Evaluates Drug Interaction with Mitiglinide and Pioglitazone

AstraZeneca is conducting a study to assess the pharmacokinetics of mitiglinide and pioglitazone when administered with AZD5004.

ClinicalJuly 17, 2026

AstraZeneca's Study on MET Concordance in Treatment-Naïve NSCLC

AstraZeneca is conducting a multicenter study to assess MET concordance and gene profiling in treatment-naïve non-small cell lung cancer (NSCLC).

ClinicalJuly 14, 2026

AstraZeneca's Dapagliflozin Approved for Heart Failure; Real-World Study Launched in Germany

Dapagliflozin has been approved by the European Commission for heart failure treatment, applicable to all patients regardless of ejection fraction or diabetes status.

ClinicalJuly 13, 2026

AstraZeneca's Rilvegostomig Study Targets Advanced Solid Tumors with Subcutaneous Administration

AstraZeneca is investigating the pharmacokinetics and safety of subcutaneous rilvegostomig in adults with advanced solid tumors.

ClinicalJuly 10, 2026

AstraZeneca Evaluates Surovatamig for CLL/SLL Consolidation Therapy

AstraZeneca is conducting a trial to assess the safety and efficacy of Surovatamig as consolidation therapy in CLL/SLL patients with unmutated IGHV.

ClinicalJuly 9, 2026

AstraZeneca's Wainua fails primary endpoint in ATTR-CM Phase III trial

The CARDIO-TTRansform Phase III trial for Wainua (eplontersen) did not meet its primary efficacy endpoint.

ClinicalJuly 9, 2026

AstraZeneca's Anifrolumab Study for Systemic Lupus Erythematosus Underway

AstraZeneca is conducting a study to evaluate the pharmacokinetics, pharmacodynamics, and safety of anifrolumab in patients with systemic lupus erythematosus.

ClinicalJuly 8, 2026

AstraZeneca Investigates Safety of Ondexxya IV Injection in Real-World Use

AstraZeneca is conducting a survey to assess the safety and effectiveness of Ondexxya IV Injection 200 mg in real-world conditions.

ClinicalJuly 7, 2026

AstraZeneca's Phase III Trial of Baxdrostat in Primary Aldosteronism Underway

AstraZeneca is conducting Phase III trial to evaluate the efficacy and safety of baxdrostat in patients with Primary Aldosteronism.

ClinicalJuly 5, 2026

AstraZeneca initiates Phase I/II trial of AZD9829 for CD123+ hematological malignancies

AstraZeneca is conducting Phase I/II trial to evaluate AZD9829 in patients with CD123+ hematological malignancies.

ClinicalJuly 4, 2026

AstraZeneca's PT010 Study Targets Severe Asthma in Adults and Adolescents

AstraZeneca is conducting a study to evaluate the efficacy and safety of PT010, a combination inhaler, in patients with inadequately controlled severe asthma.

ClinicalJune 28, 2026

Durvalumab and Cetuximab Combination Trial for Head and Neck Cancer

A clinical trial is underway to evaluate the efficacy of durvalumab combined with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma.

ClinicalJune 27, 2026

Trial Compares Rivaroxaban and Ticagrelor Against Clopidogrel for Stroke Prevention

The trial aims to assess if rivaroxaban or ticagrelor, alone or in combination, is more effective than clopidogrel in reducing ischemic stroke and related outcomes.

ClinicalJune 26, 2026

AstraZeneca initiates Phase 3 extension study for Tozorakimab in COPD patients

AstraZeneca is conducting Phase 3 extension study to evaluate the long-term efficacy and safety of Tozorakimab in COPD patients with a history of exacerbations.

ClinicalJune 26, 2026

AstraZeneca's Elecoglipron Phase III Trials Target Obesity and T2DM

AstraZeneca is conducting two pivotal Phase III studies to evaluate the efficacy and safety of elecoglipron in adults with obesity or overweight, with and without T2DM.

ClinicalJune 24, 2026

Phase III Trial of Durvalumab Post-Surgery in Early-Stage NSCLC Shows Potential Benefit

The INSIGHT trial is comparing durvalumab to standard observation in patients with early-stage non-small cell lung cancer post-surgery.

ClinicalJune 23, 2026

Phase Ⅲ Trial of Rilvegostomig in HER2-positive Gastric Cancer Initiated by AstraZeneca

AstraZeneca is conducting Phase Ⅲ trial to evaluate rilvegostomig combined with fluoropyrimidine and T-DXd in HER2-positive gastric cancer.

ClinicalJune 19, 2026

Pentoxifylline and α-Tocopherol Study for RILI in Stage III NSCLC Patients

A clinical trial is investigating the efficacy of Pentoxifylline and α-Tocopherol in preventing radiation-induced lung injury in stage III NSCLC patients.

ClinicalJune 18, 2026

Phase II Trial of Olaparib and Durvalumab Combinations in Recurrent Endometrial Cancer

A phase II trial is evaluating the efficacy of combinations of olaparib, durvalumab, cediranib, and capivasertib in recurrent or refractory endometrial cancer.

ClinicalJune 18, 2026

Phase II Trial of Selumetinib and Olaparib in RAS Pathway Mutant Ovarian and Endometrial Cancers

A phase II trial is comparing the efficacy of selumetinib plus olaparib versus selumetinib alone in patients with RAS pathway mutant recurrent or persistent ovarian and endometrial cancers.

ClinicalJune 18, 2026

EVOLVE Study to Assess Real-World Effectiveness of Tezepelumab in Severe Asthma in Greece

The EVOLVE study will evaluate the real-world effectiveness of tezepelumab in uncontrolled severe asthma over two years in Greece.

ClinicalJune 17, 2026

Study on Durvalumab, Bevacizumab, and TACE for Advanced Hepatocellular Carcinoma

A clinical trial is evaluating the combination of durvalumab, bevacizumab, and TACE for advanced HCC, focusing on 6-month progression-free survival.

ClinicalJune 17, 2026

Phase III Trial of MEDI5752 in Unresectable Pleural Mesothelioma Launched

A phase III trial is underway to evaluate the efficacy and safety of MEDI5752 in combination with standard chemotherapy in patients with unresectable pleural mesothelioma.

ClinicalJune 17, 2026

Phase III Study of Durvalumab + Domvanalimab in Stage III Unresectable NSCLC Initiated

A Phase III trial is underway to evaluate the combination of durvalumab and domvanalimab in patients with unresectable NSCLC.

ClinicalJune 17, 2026

Phase III Trial of Osimertinib and Bevacizumab in EGFR-Mutant Lung Cancer

A phase III trial is comparing osimertinib alone versus its combination with bevacizumab in patients with EGFR-mutant non-small cell lung cancer.

ClinicalJune 17, 2026

Phase III Trial of Durvalumab with Chemotherapy in Stage II-III Breast Cancer

A phase III trial is evaluating the addition of durvalumab to standard chemotherapy in patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

ClinicalJune 17, 2026

Phase III Trial Evaluates Hormone Therapy and Chemotherapy in Invasive Breast Cancer

A randomized phase III trial is assessing the efficacy of tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy in invasive breast cancer.

ClinicalJune 16, 2026

Imfinzi + EV shows significant survival benefits in muscle-invasive bladder cancer

The Phase III VOLGA trial demonstrated that perioperative Imfinzi plus neoadjuvant EV significantly improves event-free survival and shows a favorable trend in overall survival for muscle-invasive bladder cancer.

ClinicalJune 16, 2026

Tozorakimab Shows Positive Phase III Results in COPD, Reducing Exacerbations

Tozorakimab met its primary endpoint in the Phase III MIRANDA trial, showing significant reduction in COPD exacerbations.

ClinicalJune 16, 2026

Ultomiris meets primary endpoint in Phase III trial for IgAN

Ultomiris showed a statistically significant reduction of proteinuria in adults with immunoglobulin A nephropathy in the Phase III I CAN trial.

Competitive activity(3)

CompetitiveJuly 29, 2026

AstraZeneca's GEMINI-PeriOp GC Study Targets Locally Advanced Gastroesophageal Adenocarcinoma

AstraZeneca's GEMINI-PeriOp GC study is evaluating novel agents or combinations for perioperative treatment in patients with locally advanced resectable gastroesophageal adenocarcinoma.

CompetitiveJuly 25, 2026

AstraZeneca Initiates Phase 1b/2 Trial of AZD0120 for Relapsed/Refractory Multiple Myeloma

AstraZeneca is conducting Phase 1b/2 trial of AZD0120, a dual CAR T-cell therapy targeting CD19 and BCMA, in patients with relapsed/refractory multiple myeloma.

CompetitiveJune 19, 2026

AstraZeneca Leads Study on DLBCL Treatment Patterns in MEA Region

AstraZeneca is sponsoring a multicenter observational study to analyze treatment patterns and access to novel therapies for DLBCL patients in the MEA region.

Assets

Amneal →
Anifrolumab →
AZD0120 →
AZD4512 →
AZD4954 →
AZD5004 →
AZD6234 →
AZD9829 →
baxdrostat →
BAXFENDY →
Brilinta →
Camizestrant →
Capivasertib →
CLDN18.2-positive advanced gastric cancers →
CRESTOR →
Dapagliflozin →
Datroway →
Durvalumab →
Elecoglipron →
Enhertu →
EPLONTERSEN SODIUM →
Etcamah →
Farxiga →
Fasenra →
FDA →
fluoropyrimidine →
IMFINZI →
immuno-oncology →
Inventia →
Ionis →
KOSELUGO →
Lynparza →
MEDI5752 →
Methapharm →
Olaparib →
Oncology →
Ondexxya →
Osimertinib →
Parexel →
paromlimab →
Pentoxifylline →
Pipeline Update →
POKONZA →
PT010 →
QL1706 →
QTERN →
Regulatory Approval →
Rivaroxaban →
SAPHNELO →
Selumetinib →
Sonesitatug →
sorafenib →
Surovatamig →
Surufatinib →
SYMBICORT AEROSPHERE →
Tamoxifen Citrate →
Tezepelumab →
Tozorakimab →
TR115 →
Trial Update →
Truqap →
Ultomiris →
Venetoclax →
Zegfrovy →

Therapeutic areas

ADC →
AKT Inhibitor →
Anticoagulant →
Antiplatelet →
Asthma →
ATTR-CM →
B-cell Non-Hodgkin Lymphoma →
Bladder Cancer →
Breast Cancer →
CAR T-cell Therapy →
Cardiology →
Cardiology · Antiplatelet →
Cardiology · ATTR-CM →
Cardiology · Electrolyte Replacement →
Cardiology · Heart Failure →
Cardiology · Heart Transplantation →
Cardiology · Hypertension →
Cardiology · Pulmonary Arterial Hypertension →
Cardiovascular →
Cardiovascular · Antiplatelet →
Cardiovascular · Dyslipidemia →
Cardiovascular · Statin →
CD123-targeted therapy →
CLL →
Combination Therapy →
Complement Inhibition →
Contraception →
COPD →
Diabetes →
Diabetes · Drug Interaction →
Diabetes · SGLT2 Inhibitor →
Diabetes · SGLT2 Inhibitor / DPP-4 Inhibitor →
DPP-4 Inhibitor →
Drug Interaction →
Dyslipidemia →
EGFR Inhibitor →
Endocrinology →
Endocrinology · Hypertension →
Endocrinology · Obesity →
Endocrinology · Primary Aldosteronism →
Endometrial Cancer →
ER-positive Breast Cancer →
Gastroesophageal Adenocarcinoma →
Head and Neck Cancer →
Heart Failure →
Hematology →
Hematology · Anticoagulant →
Hematology · CAR T-cell Therapy →
Hematology · CD123-targeted therapy →
Hematology · Multiple Myeloma →
Hematology · Thrombotic Microangiopathy →
Hepatocellular Carcinoma →
HER2-positive Breast Cancer →
HER2-positive Gastric Cancer →
Hormone Receptor-positive Breast Cancer →
Hypertension →
Immunology →
Immunology · Lupus →
Immunology · Systemic Lupus Erythematosus →
Immunotherapy →
Lung Cancer →
Lupus →
MEK Inhibitor →
Mesothelioma →
Multiple Myeloma →
Nephrology →
Nephrology · Complement Inhibition →
Neurology →
Neurology · RNA-targeted therapy →
Non-Hodgkin Lymphoma →
Non-Small Cell Lung Cancer →
Not specified →
NSCLC →
Obesity →
Oncology →
Oncology · ADC →
Oncology · AKT Inhibitor →
Oncology · B-cell Non-Hodgkin Lymphoma →
Oncology · Bladder Cancer →
Oncology · Breast Cancer →
Oncology · CLL/SLL →
Oncology · Colorectal Cancer →
Oncology · Combination Therapy →
Oncology · EGFR Inhibitor →
Oncology · Endometrial Cancer →
Oncology · ER-positive Breast Cancer →
Oncology · EZH2 Inhibitor →
Oncology · Gastroesophageal Adenocarcinoma →
Oncology · Head and Neck Cancer →
Oncology · Hepatocellular Carcinoma →
Oncology · HER2-positive Breast Cancer →
Oncology · HER2-positive Gastric Cancer →
Oncology · HER2-positive solid tumours →
Oncology · Hormone Receptor-positive Breast Cancer →
Oncology · Image-Guided Therapy →
Oncology · Immunotherapy →
Oncology · Liver Cancer →
Oncology · Lung Cancer →
Oncology · Mantle Cell Lymphoma →
Oncology · MEK Inhibitor →
Oncology · Melanoma →
Oncology · Mesothelioma →
Oncology · Neuroendocrine Tumors →
Oncology · Non-Hodgkin Lymphoma →
Oncology · Non-Small Cell Lung Cancer →
Oncology · NSCLC →
Oncology · Oropharyngeal Cancer →
Oncology · Pancreatic Cancer →
Oncology · PARP Inhibitor →
Oncology · Prostate Cancer →
Oncology · Radiation Therapy →
Oncology · Rectal Cancer →
Oncology · Solid Tumors →
Oncology · Targeted Therapy →
PARP Inhibitor →
Primary Aldosteronism →
Prostate Cancer →
Psychiatry · Weight Management →
Rare Diseases · Hypophosphatasia →
Respiratory →
Respiratory · Asthma →
Respiratory · Asthma/COPD →
Respiratory · Bronchial Challenge Test →
Respiratory · Bronchial Provocation Testing →
Respiratory · COPD →
RNA-targeted therapy →
SGLT2 Inhibitor →
SLL →
Solid Tumors →
Statin →
Stroke →
Systemic Lupus Erythematosus →
Thrombotic Microangiopathy →
Women's Health →
Women's Health · Contraception →

Indications

Asthma →
B-cell Non-Hodgkin Lymphoma →
Bladder Cancer →
Breast Cancer →
COPD →
Diabetes →
Endometrial Cancer →
ER-positive Breast Cancer →
Gastroesophageal Adenocarcinoma →
Head and Neck Cancer →
Hepatocellular Carcinoma →
HER2-positive Breast Cancer →
HER2-positive Gastric Cancer →
Hormone Receptor-positive Breast Cancer →
Lung Cancer →
Non-Hodgkin Lymphoma →
Non-Small Cell Lung Cancer →
NSCLC →
Obesity →
Prostate Cancer →
Small cell lung cancer (limited stage) →

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