One of the lessons learned from the pandemic may be that virtual meetings can be used in place of an in-person session more often.
Virtual meetings may remain a significant part of the US Food and Drug Administration’s strategy post-pandemic to improve its communications with sponsors.
Center for Drug Evaluation and Research Director Patrizia Cavazzoni said the increased flexibility allowed by virtual meetings should be a...
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
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 An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
