Pfizer and BioNTech file an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 data showing a vaccine ...
Fresenius Kabi recalls a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vial due to a trace am...
FDA issues a draft guidance with recommendations on cross labeling oncology drugs used in combination regimens.
The Stericycle recall index for the third quarter of 2020 finds that drug recalls nearly doubled, while medical device recalls fell by one-third.
FDA issues a draft guidance with additional questions and answers on biosimilar development and the Biologics Price Competition and Innovation Act.
FDA has accepted for review an Alvotech USA BLA for a Humira biosimilar.
Federal Register notice: FDA posts 30 additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support...
Federal Register notice: FDA issues an order permanently debarring Richard M. Simon from providing services in any capacity to a person that has an ap...