Pfizer Inc. (NYSE: PFE) has announced encouraging topline data from its Phase 2b clinical trial (NCT04707313) investigating danuglipron, an oral Glucagon-like peptide-1 receptor agonist (GLP-1RA), in adults with obesity but without type 2 diabetes. The study successfully met its primary endpoint, showing a statistically significant change in body weight from baseline. Effective Weight Reductions Observed […]
In a significant development for the pharmaceutical industry, Aurobindo Pharma Limited’s dedicated subsidiary, Eugia Pharma Specialities Limited, has triumphantly gained the final nod from the US Food & Drug Administration (USFDA). This monumental approval permits the manufacture and marketing of the Testosterone Cypionate Injection USP in multiple dosage configurations, which stand as bioequivalent and therapeutically […]
Lupin Limited, a recognized global pharmaceutical powerhouse, proudly announced its receipt of the much-anticipated approval from the US Food and Drug Administration (FDA). This authorization paves the way for its Abbreviated New Drug Application concerning Fluconazole Tablets USP in varying strengths: 50 mg, 100 mg, 150 mg, and 200 mg. These tablets are designed to […]
Switzerland-based Roche has officially declared its acquisition agreement for Telavant Holdings, Inc., a Roivant company collaboratively owned by Roivant Sciences Ltd. and Pfizer Inc. The spotlight of this $7.1 billion deal is on RVT-3101, a novel TL1A directed antibody, poised as a potential game-changer for nearly 8 million global inflammatory bowel disease patients, including those […]
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for ABRYSVO, its bivalent respiratory syncytial virus (RSV) prefusion F vaccine. This groundbreaking vaccine aims to protect infants through maternal immunization and individuals 60 years and older against lower respiratory tract disease (LRTD) caused by RSV. ABRYSVO Offers Dual Protection Against Severe RSV […]
The US Food and Drug Administration (FDA) has granted approval to Pfizer Inc.’s ABRYSVO, a bivalent Respiratory Syncytial Virus prefusion F (RSVpreF) vaccine. This cutting-edge vaccine is designed for the prevention of Lower Respiratory Tract Disease (LRTD) and severe LRTD caused by RSV in infants. Notably, the vaccine works through active immunization of pregnant individuals […]
Pfizer Inc. has earned accelerated approval from the U.S. Food and Drug Administration (FDA) for its innovative drug, ELREXFIO (elranatamab-bcmm). This drug aims to treat adult patients diagnosed with relapsed or refractory multiple myeloma (RRMM) who have undergone at least four previous therapy lines, including essential treatments. Rooted in Promising Clinical Trials The endorsement stems […]
Alexion, a subdivision of AstraZeneca focusing on rare diseases, has announced its definitive purchase and licensing agreement for a portfolio of preclinical gene therapy programmes from Pfizer Inc. The deal, a move to strengthen Alexion and AstraZeneca’s commitment to next-generation genomic medicines, is worth up to $1 billion, plus tiered royalties on sales. This acquisition […]
Pfizer has announced that the US Food and Drug Administration (FDA) has granted approval to LITFULO (ritlecitinib) as a once-daily oral treatment for individuals aged 12 and older with severe alopecia areata. LITFULO is the first and only FDA-approved therapy for adolescents (12+) with severe alopecia areata. The recommended dose for LITFULO is 50 mg. […]
Pfizer has obtained approval for PAXLOVID, an oral combination therapy of nirmatrelvir tablets and ritonavir tablets, from the US Food and Drug Administration (FDA) to treat adult patients with mild-to-moderate COVID-19 who are at a high risk of hospitalization or death. PAXLOVID has been available in the US since December 2021 under Emergency Use Authorization […]