Pfizer

FDA Submission Update for NURTEC ODT (Rimegepant Sulfate) by Pfizer

Pfizer has submitted a supplemental application for NURTEC ODT (Rimegepant Sulfate) under NDA212728 with a standard review priority.

FDA Accepts Supplement for NGENLA (BLA761184) from Pfizer

The FDA has accepted a supplemental application for NGENLA (BLA761184) from Pfizer, indicating progress in the regulatory process.

European Commission Approves Pfizer-BioNTech XFG-adapted COVID-19 Vaccine for 2026-2027

The European Commission has granted marketing authorization for the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for individuals 6 months and older.

Post-marketing Surveillance for Xeljanz XR to Evaluate Safety in Rheumatoid Arthritis and Related Conditions

A post-marketing surveillance study for Xeljanz XR will assess its safety and effectiveness in routine clinical practice in Korea.

FDA Grants Priority Review for TALZENNA Plus XTANDI in Metastatic Prostate Cancer

The FDA has accepted a supplemental New Drug Application for TALZENNA in combination with XTANDI for metastatic castration-sensitive prostate cancer, supported by Phase 3 TALAPRO-3 trial data.

FDA Accepts Supplemental Application for ZITHROMAX by Pfizer

The FDA has accepted a supplemental application for ZITHROMAX (azithromycin) from Pfizer.

FDA Accepts Supplemental NDA for Zithromax by Pfizer

The FDA has accepted a supplemental NDA for Zithromax (azithromycin) submitted by Pfizer.

FDA Approval Status Update for Cleocin (Clindamycin Palmitate Hydrochloride)

The FDA has updated the submission status for Cleocin, indicating an Abbreviated New Drug Application (ANDA) approval process.

FDA Approves Supplemental Application for Zithromax (Azithromycin)

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (azithromycin) submitted by Pfizer.

FDA Accepts Supplement for Zithromax (Azithromycin) by Pfizer

The FDA has accepted a supplemental application for Zithromax (azithromycin) from Pfizer.

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

FDA Approves Supplemental Application for NURTEC ODT by Pfizer

The FDA has approved a supplemental application for NURTEC ODT, an oral medication containing rimegepant sulfate.

FDA Approves PADCEV plus Keytruda for Muscle-Invasive Bladder Cancer Treatment

The FDA has approved PADCEV in combination with Keytruda as a neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer, regardless of cisplatin eligibility.

FDA Accepts Supplemental Application for XELJANZ (Tofacitinib Citrate)

The FDA has accepted a supplemental application for XELJANZ, indicating ongoing development and potential label expansion.

FDA Accepts Supplemental NDA for CIBINQO (Abrocitinib) by Pfizer

The FDA has accepted a supplemental NDA for CIBINQO (abrocitinib), indicating progress in its regulatory review.

FDA Approves Supplemental Application for XELJANZ XR by Pfizer

The FDA has approved a supplemental application for XELJANZ XR, JAK inhibitor developed by Pfizer.

FDA Approves Supplemental NDA for Pfizer's Ritlecitinib Tosylate (Litfulo)

The FDA has approved a supplemental NDA for Litfulo (ritlecitinib tosylate) submitted by Pfizer.

FDA Accepts Supplemental Application for NGENLA (Somatrogon-GHLA)

The FDA has accepted a supplemental application for NGENLA, a growth hormone therapy developed by Pfizer.

FDA Approval Update for IBRANCE (Palbociclib) by Pfizer

The FDA has accepted the supplemental application for IBRANCE (palbociclib) from Pfizer.

FDA Accepts Supplemental Application for IBRANCE (Palbociclib)

The FDA has accepted a supplemental application for IBRANCE (palbociclib) submitted by Pfizer.

FDA Approves Supplemental Application for IBRANCE (Palbociclib)

The FDA has approved a supplemental application for IBRANCE, CDK4/6 inhibitor developed by Pfizer.

FDA Approves Palbociclib with Trastuzumab for HR-positive, HER2-positive Breast Cancer

The FDA has approved palbociclib in combination with trastuzumab, with or without pertuzumab, for maintenance treatment in HR-positive, HER2-positive metastatic breast cancer.

FDA Approves Pfizer’s IBRANCE for HR+, HER2+ Metastatic Breast Cancer Maintenance

The FDA has approved IBRANCE in combination with trastuzumab and endocrine therapy for HR+, HER2+ metastatic breast cancer maintenance treatment, based on the Phase 3 PATINA trial results.

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.

FDA Approves Supplemental Applications for ZYVOX by Pfizer

The FDA has approved supplemental applications for ZYVOX (linezolid), indicating ongoing support for this antibiotic.

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 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.

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.

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.

Pfizer Reports Positive Phase 3 Results for LITFULO in Nonsegmental Vitiligo

LITFULO (ritlecitinib) demonstrated significant improvement in facial and total repigmentation in patients with nonsegmental vitiligo in two Phase 3 trials.

Pfizer's PF-08049820 Study Examines Absorption Variability in Healthy Adults

Pfizer is conducting a study to evaluate the absorption and elimination of PF-08049820 in healthy adults, assessing food and drug interactions.

Pfizer's Study on Itraconazole's Effect on PF-08642534 Pharmacokinetics

Pfizer is conducting a study to evaluate how itraconazole affects the pharmacokinetics of PF-08642534 in healthy adults.

Comparative Study of Raltitrexed and Oxaliplatin in Metastatic Colorectal Cancer

A randomized pharmacokinetic study is underway comparing biweekly and triweekly regimens of raltitrexed and oxaliplatin in metastatic colorectal cancer.

Brentuximab Vedotin and Pembrolizumab Trial for Metastatic Cancers Initiated

A new clinical trial is investigating the combination of brentuximab vedotin and pembrolizumab in patients with metastatic solid tumors.

Study on Sacituzumab Govitecan and Talazoparib in Metastatic Breast Cancer

A clinical trial is evaluating the combination of Sacituzumab Govitecan and Talazoparib in patients with metastatic triple-negative breast cancer.

Pfizer's Ibuzatrelvir Study Targets High-Risk COVID-19 Patients

Pfizer is conducting a study to evaluate the safety and efficacy of ibuzatrelvir in non-hospitalized adults and adolescents with COVID-19 at risk of severe disease.

Study on Managing Hyperlipidemia in ALK+ NSCLC Patients on Lorlatinib

A study is underway to evaluate management strategies for hyperlipidemia in patients with ALK-positive NSCLC receiving lorlatinib as first-line treatment.

Pfizer Reports Phase 3 Results for Sigvotatug Vedotin in NSCLC; No Overall Survival Benefit Observed

The Phase 3 SigVie-002 study of sigvotatug vedotin in previously treated metastatic NSCLC did not show a statistically significant improvement in overall survival compared to docetaxel, although a trend for better outcomes was noted in patients with only one prior therapy.

Pilot Study on Text-Based Contingency Management for Smoking Cessation Engagement

A pilot study is assessing the feasibility of a text-based contingency management intervention to enhance engagement in smoking cessation treatment.

Study on Host-Pathogen Interaction with Staphylococcus aureus Using Lymphoid Organoids

A study is being conducted to understand the interaction between Staphylococcus aureus and human cells using tonsil tissues.

Study Reveals Mucus-Plug Dynamics in COPD Patients and Ex-Smokers

In a study of ex-smokers, mucus-plugs persisted in one-third of patients with COPD, while new plugs developed in others, indicating complex dynamics.

Study Evaluates ePRO Follow-Up for Oncology Patients Post-Hospitalization

The study assesses the feasibility of using electronic patient-reported outcomes (ePRO) and transitional nurse consultations for oncology patients post-discharge.

ACT vs CBT Trial for Psychological Distress in HIV/AIDS Patients

A randomized controlled trial is underway comparing Acceptance and Commitment Therapy and Cognitive Behavioral Therapy in HIV/AIDS patients.

ComboMATCH Trial Targets Genetic Mutations in Advanced Solid Tumors

The ComboMATCH trial aims to match patients with advanced solid tumors to targeted therapies based on genetic testing.

Cardiff Oncology and Pfizer assess onvansertib in metastatic colorectal cancer trial

A clinical trial is underway to evaluate onvansertib combined with standard therapies for first-line treatment of KRAS/NRAS-mutated metastatic colorectal cancer.

Study on Exercise Program's Impact on Quality of Life in Prostate Cancer Patients

A clinical trial is assessing the effects of a structured exercise program on quality of life and health outcomes in prostate cancer patients.

Study Reveals Risk Factors for Second Primary Cancer in Colorectal Cancer Survivors

The study identifies age, neoadjuvant therapy, and tumor characteristics as risk factors for second primary cancer in colorectal cancer survivors.

Study on Socio-aesthetics Care Impact on Cancer Patients' Quality of Life

A randomized controlled trial is evaluating the impact of socio-aesthetics well-being care on quality of life, pain, and anxiety in cancer patients.

Pfizer's Phase 3 Study of Tofacitinib in Pediatric Ulcerative Colitis Underway

Pfizer's ELREXFIO Shows Significant PFS Improvement in RRMM Patients

The Phase 3 MagnetisMM-5 trial demonstrated a statistically significant improvement in progression-free survival for ELREXFIO in patients with relapsed or refractory multiple myeloma compared to standard-of-care.

Pfizer's 25vPnC Vaccine Shows Strong Phase 2 Results, Advancing to Phase 3

Pfizer's Berobenatide Shows Promising Phase 2b Results for Monthly Dosing in Obesity Management

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.

TALZENNA Plus XTANDI Shows 52% rPFS Improvement in Metastatic Prostate Cancer

The Phase 3 TALAPRO-3 study demonstrated that TALZENNA plus XTANDI significantly improved radiographic progression-free survival (rPFS) by 52% in patients with HRR gene-altered metastatic prostate cancer.

Pfizer’s BRAFTOVI Regimen Nearly Doubles Progression-Free Survival in mCRC

The Phase 3 BREAKWATER study showed BRAFTOVI combined with cetuximab and FOLFIRI nearly doubled median progression-free survival to 15.2 months compared to 8.3 months with the comparator.

Pfizer Initiates Study on New Pneumococcal Vaccine for Infants

Pfizer is conducting a study to evaluate the safety and efficacy of a new pneumococcal vaccine (PG4) in infants compared to the existing Prevnar 20® vaccine.

Pfizer and Innovent Collaborate on 12 Early-Stage Oncology Programs

Pfizer and Innovent Biologics have entered a strategic collaboration to co-develop 12 early-stage cancer medicines, including antibody-drug conjugates.