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- Business Wire
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union
NEW YORK & MAINZ, Germany, June 27, 2024--Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the
- GlobeNewswire
BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer
Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration (“FDA”) to support development and expedite regulatory reviewProstate cancer is
- Benzinga
Covid-19 Pharma Stars Continue Their Quest To Set New Standards In Cancer Treatment
AstraZeneca PLC (NASDAQ: AZN) kicked off the week by receiving approval from the U.S. Food and Drug Administration for its blockbuster cancer drug Imfinzi combined with chemotherapy being used as a treatment forpatients suffering from specific type of endometrial cancer. Its pharma peer, BioNTech SE (NASDAQ: BNTX) wasn’t as lucky as also on Monday, the FDA put its experimental cancer drug study on partial clinical hold. Combining Immunotherapy And Chemotherapy Is Emerging As A New Standard In Ca
