Clinical Trials
Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma
Bristol Myers Squibb and 2seventy bio, Inc.announced positive topline results from KarMMa-3, a Phase 3, global, randomized, multicenter, open-label study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory...
Drug Research
West Makes Minority Investment in Dublin-Based Latch Medical, a Developer of Vaccine and Biologics Delivery Platforms
West Pharmaceutical Services, Inc. , a global leader in innovative solutions for injectable drug administration, announced it has made a strategic investment in Latch Medical, a Dublin-based leader in next-generation vaccine and biologics delivery technology that is pioneering a...
Press Releases
Novavax Nuvaxovid COVID-19 Vaccine Approved in South Korea for Use in Adolescents Aged 12 Through 17
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS)...
Press Releases
Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
Roche announced that the US FDA has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who...
Drug Research
Thermo Fisher Announced FDA Approves First NGS-Based Companion Diagnostic to Aid in Selecting Non-Small C
The U.S. FDA has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell...
Press Releases
Gerresheimer invests up to 94 million Dollar in US production facility
Gerresheimer AG, a leading provider of healthcare & beauty solutions and drug delivery systems for pharma, biotech and cosmetics, announced investments to rapidly expand its manufacturing, supply and logistics capability for glass vials in the U.S. The project will...
Press Releases
Charles River Receives EMA Approval to Produce Allogeneic Cell Therapy
Charles River Laboratories, International Inc. announced it has received regulatory approval, in the form of Good Manufacturing Practice (GMP) certification, to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European Medicines Agency (EMA).
The approval...
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