The latest drug development news and highlights from our US FDA Performance Tracker.
Here's your news in brief: Gene therapies are continuing to make their way onto the scene, with Kite Pharma Inc.'s chimeric antigen receptor T-cell (CAR-T) therapy Yescarta (axicabtagene ciloleucel) becoming the second gene therapy to win a US FDA approval.
Pacira Pharmaceuticals Inc.and Charleston Laboratories Inc. are both working their way back from complete response letters (CRLs) for...
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
