EMA Decision

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.

Phase 2 Study of Ruxolitinib in Chronic Myelomonocytic Leukemia Shows Potential for Improved Outcomes

A Phase 2 expansion study is underway to evaluate the efficacy of ruxolitinib in patients with CMML.

Regeneron initiates trial for pozelimab + cemdisiran in PNH patients unresponsive to C5 inhibitors

Regeneron is conducting a study to evaluate the efficacy of pozelimab and cemdisiran in PNH patients inadequately controlled by existing therapies.

Semaglutide (Wegovy) approved for metabolic-associated steatohepatitis treatment

Semaglutide injection has received approval for the treatment of metabolic-associated steatohepatitis in adults with moderate-to-advanced liver fibrosis.

Eisai's E6742 Shows Promise in Systemic Lupus Erythematosus Study

E6742 is being evaluated for efficacy in systemic lupus erythematosus compared to placebo, with results expected at Week 24.

Eli Lilly initiates Phase 1 trial of oral IDH inhibitor LY3410738 in hematologic malignancies

Eli Lilly is conducting Phase 1 trial of LY3410738, targeting patients with IDH1 or IDH2 mutations in advanced hematologic malignancies.

Study on Risk Stratification in Infantile Hemangioma With Minimal Growth Initiated

A prospective observational study is underway to evaluate management strategies for infants with IH-MAG compared to classic hemangiomas.

Phase II/III Trial Evaluates Azacitidine with Lenalidomide or Vorinostat in Myelodysplastic Syndromes

A randomized phase II/III trial is investigating the efficacy of azacitidine combined with lenalidomide or vorinostat in patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.

Modeling Hyperthermia-Enhanced Delivery of Doxorubicin in Solid Tumors

Mathematical modeling shows that timing hyperthermia with peak plasma TSL-DOX levels can double intracellular doxorubicin concentration.

FDA Accepts Supplement Application for RYTELLO (Imetelstat Sodium)

The FDA has accepted the supplemental application for RYTELLO, an imetelstat sodium product.

Estrogen Fluctuations Linked to Increased Depression in Postmenopausal Women

Estrogen fluctuations during menopause significantly increase the risk of depression and anxiety in women.

Phase I Trial of Pacritinib with Venetoclax and Azacitidine for Myeloproliferative Neoplasms

A Phase I trial is investigating the combination of pacritinib, venetoclax, and azacitidine for treating accelerated and blast phase myeloproliferative neoplasms.

RNA Modifications as Key Regulators in Cancer Translational Control and Therapeutic Strategies

RNA modifications play a critical role in regulating protein synthesis in cancer cells, influencing therapeutic design.

GSK's Belantamab Mafodotin Study Targets Multiple Myeloma with Renal Impairment

A study is underway to evaluate the safety and pharmacokinetics of belantamab mafodotin in multiple myeloma patients with varying degrees of renal impairment.

FDA Approves Casgevy for Young Children with Sickle Cell Disease

The FDA has granted supplemental approval for Casgevy for young children with sickle cell disease and transfusion-dependent β thalassemia.

Novartis initiates pediatric study for asciminib in Chronic Myeloid Leukemia

Novartis is conducting a study to evaluate the dose and safety of asciminib in pediatric patients with Chronic Myeloid Leukemia.

FDA Accepts Supplement Application for BESREMI (Ropeginterferon Alfa-2b-NJFT)

The FDA has accepted the supplemental application for BESREMI, a treatment involving Ropeginterferon Alfa-2b-NJFT.

FDA Approves Ferric Carboxymaltose ANDA212572 by Mylan Labs

The FDA has approved the Abbreviated New Drug Application (ANDA) for Ferric Carboxymaltose submitted by Mylan Labs.

FDA Approves ANDA217769 for Ferric Carboxymaltose by Mylan

The FDA has granted approval for the Abbreviated New Drug Application ANDA217769 for Ferric Carboxymaltose submitted by Mylan.

FDA Approves Allogeneic T Cell Immunotherapy for Hematologic Malignancies

The FDA has approved a new allogeneic regulatory T cell-based immunotherapy for use in matched donor hematopoietic stem cell transplantation.

FDA Approves TREGZI for Chronic GVHD in Blood Cancer Patients

The FDA has approved TREGZI, the first Treg cell-based immunotherapy for chronic GVHD-free survival in blood cancer patients.

Phase 3 Trial of C1 Esterase Inhibitor for Acute Hereditary Angioedema by Octapharma

Octapharma is conducting a phase 3 trial of C1 esterase inhibitor concentrate for treating acute hereditary angioedema.

Phase 3 Trial of Navenibart for Hereditary Angioedema Initiated by Astria Therapeutics

Astria Therapeutics has initiated Phase 3 trial for navenibart in patients with hereditary angioedema.

Sex-based differences in TLR agonist efficacy for early-stage melanoma treatment

Intradermal delivery of TLR9 agonist CPG7909 shows sex-based differences in immune response, with men exhibiting superior dendritic cell maturation. TLR7/8 agonist resiquimod shows better activation in female patients.

FDA Drug Trials Snapshot: YARTEMLEA Approved for TA-TMA

YARTEMLEA has been approved for treating TA-TMA in patients aged 2 and older.

Trial Evaluating Levofloxacin for Infection Prophylaxis in MDS and AML Patients

A randomized controlled trial is assessing the safety and effectiveness of levofloxacin in reducing infection risk in MDS and AML patients undergoing outpatient chemotherapy.

FDA Approves Supplemental Application for AJOVY (Fremanezumab)

The FDA has approved a supplemental application for AJOVY, a migraine treatment by Teva Pharmaceuticals.

Novo Nordisk Tests UBT251 for Type 2 Diabetes in New Clinical Trial

Novo Nordisk is conducting a clinical trial to evaluate the efficacy and safety of UBT251 in patients with type 2 diabetes.

Roche Launches AXELIOS 1 Next-Generation Sequencing Platform

Roche has launched AXELIOS 1, a next-generation sequencing platform utilizing innovative SBX technology for rapid and accurate whole-genome sequencing.

Microperimetry Predicts Outcomes in Diabetic Macular Oedema Treated with Anti-VEGF

Baseline microperimetry and metabolic status are predictive of functional outcomes in DME patients receiving anti-VEGF therapy.

Phase IIa Trial of Metformin for Preventing Oral Cancer in Premalignant Lesions

A phase IIa trial is investigating the efficacy of metformin hydrochloride in preventing oral cancer in patients with premalignant lesions.

Phase II Trial of MRD-Guided Zanubrutinib and Sonrotoclax in High-Risk CLL/SLL Patients

A phase II clinical trial is underway to evaluate the efficacy and safety of zanubrutinib combined with sonrotoclax in treatment-naïve high-risk CLL/SLL patients.

Lilly's Jaypirca recommended for EU approval in CLL across all therapy lines

The CHMP has issued a positive opinion for Lilly's Jaypirca (pirtobrutinib) for adults with CLL.

Study on Gynecological Complications Post Stem Cell Transplantation

A study is investigating the prevalence of gynecological complications in women after allogeneic hematopoietic stem cell transplantation.

Phase III Trial Compares Stereotactic Radiosurgery to HA-WBRT in Brain Cancer Patients

A phase III trial is underway to evaluate the efficacy of stereotactic radiosurgery versus hippocampal avoidance whole brain radiation therapy combined with memantine in patients with small cell lung cancer that has metastasized to the brain.

Study on Factors Regulating Mast Cell Proliferation in Mastocytosis

A study is being conducted to examine growth factors affecting mast cell proliferation in patients with mastocytosis.

JNJ-68284528 (cilta-cel) vs Standard Therapy in Multiple Myeloma Study Initiated

A study is underway comparing the efficacy of JNJ-68284528 (cilta-cel) against standard therapies in multiple myeloma.

IRON-DEP Study Evaluates IV vs Oral Iron for Postpartum Depression in Anemia

The IRON-DEP Study aims to compare the efficacy of intravenous and oral iron treatments on postpartum depression prevalence in women with moderate iron deficiency anemia post-caesarean.

Novartis conducts safety study of Iptacopan in PNH patients using registry data

Novartis is conducting a post-authorization safety study of Iptacopan in adult PNH patients using data from the IPIG PNH registry.

FDA Approves First Generic of Priftin (rifapentine) Tablets

The FDA has approved the first generic version of Priftin (rifapentine) tablets for treating active pulmonary tuberculosis.

Phase I Trial of Lentiviral Gene Therapy for Hemophilia A Initiated

A Phase I trial is underway to evaluate the safety and efficacy of lentiviral gene therapy for hemophilia A.

Agios Pharmaceuticals' Mitapivat Shows Promise in Non-Transfusion-Dependent Thalassemia Study

A study is evaluating the efficacy and safety of mitapivat in patients with non-transfusion-dependent thalassemia.

mRNA-LNP Vaccine TP0435 Shows Promise Against Syphilis in Animal Models

The TP0435 mRNA-LNP vaccine demonstrated strong protective immunity against Treponema pallidum in rabbits, outperforming protein vaccines.

Study on APL-like Acute Myeloid Leukemia and Vascular Complications Initiated

A multicenter observational study is investigating the APL-like subset of acute myeloid leukemia as a predictor of coagulopathy and early vascular events.

FDA Grants Approval for Eltrombopag Olamine ANDA208815

The FDA has granted approval for ANDA208815, a generic version of Eltrombopag Olamine by Actavis Labs.

FDA Grants Approval for Fostamatinib Disodium ANDA217329

The FDA has granted approval for ANDA217329, a generic application for Fostamatinib Disodium submitted by Annora Pharma.

FDA Grants Priority Review for Pfizer's Marstacimab (BLA761369)

The FDA has granted priority review status for Pfizer's BLA761369, containing the active ingredient Marstacimab.

Phase I/II Trial of 211At-BC8-B10 in High-Risk Acute Leukemia and Myelodysplastic Syndrome

A phase I/II trial is evaluating the safety and dosing of 211At-BC8-B10 followed by donor stem cell transplant in patients with relapsed or refractory high-risk acute leukemia or myelodysplastic syndrome.

SBRT and IL-12 in PDAC: Local Therapy Alters Bone Marrow Hematopoiesis

Localized SBRT and IL-12 treatment in PDAC showed significant effects on bone marrow, including acute lymphopenia and altered hematopoiesis.

Development of Pediatric cGVHD Symptom Scale to Enhance Patient Reporting

A new questionnaire for assessing symptoms of chronic graft-versus-host disease in children/adolescents is being developed.

Semaglutide tablet approved in the UK for weight loss

The semaglutide tablet has received approval from the MHRA for weight loss and management in the UK.

Phase I/II Trial of Abemaciclib with Gemcitabine for Advanced Soft Tissue Sarcoma

A phase I/II trial is evaluating the safety and efficacy of abemaciclib combined with gemcitabine versus gemcitabine with docetaxel in patients with advanced soft tissue sarcoma.

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

The FDA has granted priority review status for the supplemental application of Marstacimab (HYMPAVZI) by Pfizer.

FDA Accepts Supplement for AJOVY (Fremanezumab) by Teva Pharmaceuticals

The FDA has accepted a supplemental application for AJOVY (fremanezumab) from Teva Pharmaceuticals.

Fremanezumab Trial for Acute Mountain Sickness Shows Potential for CGRP Blockade

A clinical trial is investigating the efficacy of fremanezumab in preventing symptoms of acute mountain sickness (AMS) in healthy adults.

Venetoclax-Dexamethasone Trial for t(11;14) Relapsed/Refractory Amyloidosis Initiated

A clinical trial is underway to evaluate the safety and efficacy of venetoclax combined with dexamethasone for relapsed or refractory t(11;14) light chain amyloidosis.

Systematic review on EGFR alterations in recurrent glioblastoma therapy response

The review assesses the predictive value of EGFR amplification and EGFRvIII mutation for EGFR-targeted therapy in recurrent glioblastoma.

Study on Hemato-immunological Parameters in Immune Thrombocytopenic Purpura

A study is underway to identify hemato-immunological parameters that predict the chronicity of Immune Thrombocytopenic Purpura (ITP) and differences between pediatric and adult populations.

Guidance on Distinction Between Angioedema Types for ACE-Inhibitor Users

Healthcare professionals are advised about the delayed onset of angioedema and the differing treatment strategies for bradykinin- versus histamine-mediated cases.

Advancements in NK Cell-Based Immunotherapy for Cancer Treatment

NK cell therapies are advancing with promising safety profiles and clinical applicability, leveraging various innovative strategies.

Lilly to present positive Phase 3 results for pirtobrutinib in CLL at EHA 2026

Apotex Inc. Submits ANDA for Ruxolitinib

Apotex Inc. has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating a move to enter the market.

FDA Proposes Exclusion of Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List

The FDA has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, indicating no clinical need for compounding these drugs.

FDA Lists Quinacrine Hydrochloride for Compounding in Cutaneous Lupus Erythematosus

Quinacrine is included on the FDA 503B list for compounding, indicating a clinical need for its use in treating cutaneous lupus erythematosus.

SillaJen initiates Phase 1 trial of BAL0891 in advanced solid tumors and AML

SillaJen is conducting Phase 1 trial of BAL0891, evaluating its safety and tolerability in advanced solid tumors and relapsed/refractory AML.

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

A study is underway to evaluate nemtabrutinib against ibrutinib or acalabrutinib in treatment-naive CLL/SLL patients.

FDA Draft Guidance Aims to Reduce Animal Testing for Cancer Drugs

The FDA has issued draft guidance to minimize unnecessary animal testing in the development of cancer drugs.

Phase III Trial of Hemay005 in Chinese Patients with Ulcerative Colitis Initiated

A phase III trial has been initiated to evaluate Hemay005 for the treatment of moderately to severely active ulcerative colitis in Chinese patients.

FDA Accepts Roche's Gazyva for Systemic Lupus Erythematosus Treatment

The FDA has accepted Roche's sBLA for Gazyva/Gazyvaro, based on phase III ALLEGORY data showing significant efficacy in SLE.

Roche Reports Strong Q1 2026 Sales Growth Driven by Innovative Medicines and Diagnostics

Roche's Q1 2026 sales grew 6% at constant exchange rates, driven by strong demand for innovative medicines, particularly in multiple sclerosis and oncology.

CVS Caremark to cover Foundayo and Zepbound, enhancing access for obesity treatment

CVS Caremark will cover Foundayo starting June 1 and Zepbound from October 1, allowing eligible patients to pay as low as $25 monthly.

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.

European Commission Approves Pfizer’s HYMPAVZI for Hemophilia A and B Treatment

The European Commission has approved HYMPAVZI for treating hemophilia A or B in patients 12 years and older with inhibitors, based on Phase 3 data showing significant bleed reduction.

Lilly's Foundayo shows superior A1C reduction and weight loss in pivotal diabetes trials

Foundayo (orforglipron) demonstrated a 57.1% greater reduction in A1C and significant weight loss compared to oral semaglutide in pivotal trials.

Lilly's Foundayo shows superior results in Phase 3 trial for type 2 diabetes

Phase 3 ACHIEVE results indicate Foundayo outperformed oral semaglutide and dapagliflozin in treating type 2 diabetes.

Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion for Muscle-Invasive Bladder Cancer

The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.

Roche and Nurix Collaborate on BTK Degrader Bexobrutideg for B-cell Malignancies

Roche has entered a collaboration with Nurix Therapeutics to co-develop bexobrutideg, a novel BTK degrader targeting B-cell malignancies, immunology, and neurology.

Pfizer's LORBRENA CROWN Trial Reports Longest Progression-Free Survival in Advanced NSCLC

The seven-year analysis of the CROWN trial shows a 55% likelihood of remaining alive without disease progression for patients treated with LORBRENA, with median progression-free survival not reached.

Lilly's Jaypirca shows 45% reduction in disease progression risk in CLL/SLL

Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax regimen in previously treated CLL/SLL patients.

Lilly presents promising Phase 1 data for first-in-class type II JAK2 inhibitor in myelofibrosis

Lilly's AJ1-11095, a type II JAK2 inhibitor, shows an encouraging safety profile and promising clinical activity in myelofibrosis patients.

FDA Approves Pfizer’s HYMPAVZI for Expanded Hemophilia A and B Indications

The FDA has approved an expanded indication for Pfizer’s HYMPAVZI to treat hemophilia A or B in patients aged 6 and older, including those with inhibitors.

Enhertu recommended for EU approval in HER2+ metastatic solid tumours

Enhertu has been recommended for approval by the CHMP for patients with previously treated HER2-positive metastatic solid tumours.

Zhuochuming® Trial Evaluates 3+T&E vs 3+PRN in Diabetic Macular Edema

A clinical trial is underway to compare the efficacy of Zhuochuming® using a 3+T&E regimen against a 3+PRN regimen in treating treatment-naïve patients with diabetic macular edema.