FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that some devices may ruptur...
The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement action against Hims & H...
Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are likely to run afoul of...
FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.
FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspection findings (not spec...
Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by CEO Albert Bourla sug...
Roche reports that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in a Phase 3 study whe...
FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of certain lower-cost ...
