FDA publishes a guidance on the types of changes to an approved BLA to be documented in an annual report.
The Justice Department says Entellus Medical and the owner of a Georgia surgical practice will pay $4.2 million to resolve a whistleblowers False Clai...
A CDER Manual of Policies and Procedures outlines policies and responsibilities of meeting participants when they are working remotely and using Web-b...
FDA lifts a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapopt, with acalabrutin...
FDA grants Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and o...
FDA issues a draft guidance with recommendations for developing drugs or biological products to treat chronic rhinosinusitis with nasal polyps.
FDA issues a guidance with recommendations for the development of pediatric anti-infective drug products.
FDA approves a Thermo Fisher Scientific PMA for its Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer pati...