FDA clears an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency use in 2021.
Federal Register notice: FDA classifies the container system for the processing and storage of red blood cell components under reduced oxygen conditio...
FDA approves Takedas Adzynma, a recombinant protein product designed for prophylactic or on‑demand enzyme replacement therapy in both adult and ...
The CDER Office of Therapeutic Biologics and Biosimilars recommends expiration dates for first interchangeable exclusivity for Boehringer Ingelheims C...
FDA approves an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in obese adults who are on a reduced cal...
CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent plasma therapy in the n...
Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.
Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from entering into pay-for...
