Press Releases

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...

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...

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...

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...

WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, announced a licensing agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”). Under this agreement, WuXi ATU will license to...

Mayne Pharma Group Limited announced that it has entered into an agreement with Catalent, Inc., the global leader in enabling biopharma, cell, gene, and consumer health partners to optimise development, launch, and supply of better patient treatments across multiple...

Lonza has launched the Nebula® Multimode Reader, the first multimode reader qualified for use with Lonza’s turbidimetric, chromogenic and recombinant endotoxin detection methods. Users can now directly compare results from absorbance-based and fluorescence-based endotoxin assays in one reader, reducing...