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Pharma News for Merck, Roche, AbbVie, Abbisko Pfizer
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...

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Another Feather in the Cap for Xtandi and Keytruda — The Two Main Cancer Drugs

The FDA has approved label extensions for two of the most crucial cancer medications globally—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expanded indication now includes stomach cancer, permitting its usage alongside chemotherapy for first-line treatment in patients with locally advanced unresecta...

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Pharma News for AskBio, Almirall, Bayer, Pfizer
Key Updates on Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type; European Commission Approves EBGLYSS; Bayer Stopped OCEANIC-AF Study; Pfizer and Astellas’ XTANDI Approved by FDA; FDA Orphan Drug Designation to Epic Bio’s EPI-321; FDA Fast Track Designation to Chemomab’s CM-101 for PSC

AskBio Announces First Patient Randomized in Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type Asklepios BioPharmaceutical, Inc., a gene therapy firm fully owned and independently operated under Bayer AG, announced the initiation of the Phase I REGENERATE MSA-101 clinical trial ...

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Pharma News for Pfizer, UCB, BioMarin
FDA Approves PENBRAYA for Most Common Serogroups Causing Meningococcal Disease; BIMZELX Approved Moderate to Severe Plaque Psoriasis; FDA Approves BioMarin’s VOXZOGO; FDA Fast Track Designation to ANPD001 for Parkinson’s Disease; UCB Announces FDA Approval of ZILBRYSQ; EMA Granted Orphan Drug Designation to Lisata’s LSTA1

UCB announces FDA approval of ZILBRYSQ for the Treatment of Adults with Generalized Myasthenia Gravis On the 17th of October 2023, UCB (Euronext Brussels: UCB) made an announcement regarding the approval of ZILBRYSQ® (zilucoplan) by the US FDA for the management of generalized myasthenia gravis (gMG) in adult pa...

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New Player in Ulcerative Colitis Treatment: Pfizer’s Etrasimod Entry Counters BMS’ Zeposia

Bristol Myers Squibb’s Zeposia has lost its exclusive status as the sole S1P receptor modulator available for ulcerative colitis treatment. The FDA has granted approval for Pfizer’s ulcerative colitis medication, Etrasimod, under the brand name Velsipity. This decision comes after the publication of Phase III resul...

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Eli Lilly’s Obesity Treatment Drug Candidates – A Show for the Competitors

On 26 June 2023, the rush to develop obesity therapies appeared to have raised the bar, as an experimental weight-loss drug from US pharma company Eli Lilly yielded the greatest effects of any treatment observed thus far. The American Diabetes Association’s annual meeting has brought the competitive dynamics of ...

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Pharma News for Pfizer, Sarepta, FibroGen, Erasca
FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma

FDA Approves Jardiance for the Treatment of Type 2 Diabetes in Children 10 Years and Older Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years and older w...

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Pharma News for Pfizer, Daiichi Sankyo, Kyverna, Servier
Daiichi Sankyo’s Intravenous Iron Replacement Therapy; ANeuroTech’s Adjunctive Anti-depression Drug, ANT-01; Kyverna Therapeutics’s KYV-101 in Lupus Nephritis; Servier Presents Data from Phase 3 INDIGO Trial of Vorasidenib; FDA Approves Pfizer’s ABRYSVO

FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults Pfizer Inc. announced that the FDA has authorized ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory...

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GSK Is All Set To Launch Respiratory Syncytial Virus Vaccine… Now Who’s Next?

Infections due to respiratory syncytial virus (RSV) have seriously troubled drug makers for decades and the need for a vaccine was on since the 1960s. According to the assessment done by DelveInsight on the latest published “Respiratory Syncytial Virus Epidemiology Report,” it is estimated to affect approximately 5...

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Respiratory Syncytial Virus Treatment Market: A Complex Space Worth Billions!

Respiratory syncytial virus is estimated to affect approximately 5 million cases this year in the United States and 2.5 million RSV cases in the EU4 countries and the United Kingdom. As per Delveinsight analysis on the latest published “Respiratory Syncytial Virus Epidemiology Report,” the US comprised ~70%, ~27%, ...

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