Tag: Pfizer

Regulatory Approval News Oncology

Pfizer’s BRAFTOVI Receives FDA Full Approval for First-Line Metastatic Colorectal Cancer Treatment

pfizer news

Pfizer announced FDA full approval of BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for treating adults with BRAF V600E-mutant metastatic colorectal cancer. The landmark approval is backed by Phase 3 BREAKWATER trial data demonstrating a 51% reduction in mortality risk and 47% reduction in disease progression risk compared to standard chemotherapy.

Clinical Trials News Oncology

Pfizer’s BRAFTOVI Regimen Demonstrates Significant Progression-Free Survival Benefit in Advanced Colorectal Cancer

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Pfizer announced positive progression-free survival results from BREAKWATER trial Cohort 3, showing BRAFTOVI combined with cetuximab and FOLFIRI achieves statistically significant and clinically meaningful progression-free survival improvement compared to chemotherapy alone in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.

News Healthcare & Pharmaceuticals Regulatory

Pfizer’s HYMPAVZI Receives FDA Priority Review to Expand Treatment to Children and Patients with Hemophilia A or B Without Inhibitors

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Pfizer has reached a major regulatory milestone with the FDA granting Priority Review for HYMPAVZI™ (marstacimab) to include children as young as six and patients with hemophilia inhibitors. If approved, HYMPAVZI would become the first non-factor prophylactic treatment for children aged 6–11 with hemophilia B, offering a simplified, once-weekly injection that addresses a massive unmet medical need in the rare disease community.

Clinical Trials Anti-obesity Drugs News Weight-loss Drugs

Pfizer’s Monthly Obesity Shot Delivers 12% Weight Loss in Milestone Phase 2b Trial

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Pfizer’s investigational “ultra-long-acting” GLP-1 receptor agonist, PF-08653944, showed robust 12.3% weight loss in its Phase 2b VESPER-3 study. Transitioning from weekly to a once-monthly injection, the drug maintained high efficacy and tolerability, positioning Pfizer as a major competitor in the 2026 obesity drug market.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Approves PADCEV® and KEYTRUDA® Combo for Patients with Bladder Cancer

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The FDA has granted approval for PADCEV® plus KEYTRUDA® as a perioperative treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). Clinical data reveals the combination reduces the risk of recurrence, progression, or death by 60% compared to surgery alone, marking a major shift in the standard of care.

Clinical Trials News Oncology

Breakthrough in Bladder Cancer Treatment: PADCEV and KEYTRUDA Combination Significantly Improves Survival

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A landmark clinical trial reveals a powerful new weapon against aggressive bladder cancer. The combination of PADCEV™ and KEYTRUDA®, administered before and after surgery, has been shown to significantly improve survival rates for patients with muscle-invasive bladder cancer who are ineligible for cisplatin chemotherapy. These groundbreaking results could establish a new standard of care, offering profound hope for a patient population with previously limited options.

Business Healthcare & Pharmaceuticals News

Pfizer Acquires Metsera in $4.9 Billion Deal, Bolsters Obesity Drug Portfolio

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Pfizer has announced a definitive agreement to acquire clinical-stage biopharmaceutical company Metsera in a deal valued at an initial $4.9 billion, with the potential for an additional $2.4 billion in milestone payments. The acquisition is a strategic move to re-enter the lucrative weight-loss drug market by adding Metsera’s next-generation obesity and cardiometabolic disease treatments, including promising oral and injectable therapies, to Pfizer’s pipeline.

Regulatory Approval Healthcare & Pharmaceuticals News Vaccines

FDA Approves Pfizer-BioNTech COVID-19 Vaccine for High-Risk Adults and Seniors

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Pfizer and BioNTech’s updated COMIRNATY vaccine, targeting the LP.8.1 COVID-19 sublineage, gained FDA approval for use in seniors and high-risk individuals aged 5 to 64. The vaccine promises enhanced immune defense against current variants and is set for immediate distribution across the U.S.

Business News

Pfizer Reports Strong Q2 2025 Results, Raises Full-Year EPS Guidance

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Pfizer delivered robust Q2 2025 results, reporting $14.7 billion in revenue (up 10% operationally) and $0.78 adjusted EPS. Key drivers included double-digit growth from Comirnaty, Paxlovid and Abrysvo. The company raised its full-year adjusted EPS guidance to $2.90–3.10 while reaffirming revenue outlook of $61.0–64.0 billion, underscoring strong commercial execution and cost-saving initiatives.