FDA refuses to file a BrainStorm Cell Therapeutics BLA for its NurOwn to treat ALS.
Yale University researchers say FDA should strengthen its regulatory approach to artificial intelligence products used in breast cancer screening.
Federal Register notice: FDA makes available a draft guidance entitled Sameness Evaluations in an ANDA Active Ingredients.
FDAs Pulmonary-Allergy Drugs Advisory Committee votes 16 to 1 to support approval of an AstraZeneca NDA for PT027 (albuterol/budesonide) for treating ...
ZoomRx suggests three ways to create effective oncology promotional messages directed to healthcare providers.
FDA says Insulet has issued a correction for its Omnipod DASH personal diabetes managers due to issues with the batteries.
FDA grants an emergency use authorization to Swedish Orphan Biovitrum for its Kineret to treat some adults hospitalized with Covid-19.
Federal Register notice: FDA cancels an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (nir...
FDA releases the form FDA-483 issued following an inspection at the Lupin manufacturing facility in Pune, Maharashtra, India.