FDA publishes an International Council on Harmonization Question and Answer guidance to clarify its M12 guidance on drug interaction studies.
Sens. Durbin and Cassidy introduce the bipartisan REMEDY Act to discourage innovator drug companies from filing additional patents to delay generic co...
FDA clears a Teleflex 510(k) for its Ringer Perfusion Balloon Catheter for use in percutaneous transluminal coronary angioplasty procedures.
Federal Register notice: FDA renews its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charter expiration date.
FDA says its new LabelComp artificial intelligence tool automates the identification of adverse event changes in drug labeling updates.
FDA approves an sBLA expanding the endometrial cancer indication for GlaxoSmithKlines Jemperli.
Abbott issues a medical device correction for a small number of FreeStyle Libre 3 sensors because they may provide incorrect high glucose readings.
Novartis files a lawsuit against FDA that seeks to reverse the agencys recent approval of MSN Laboratories generic version of Novartiss Entresto (sacu...
