Federal Register notice: FDA seeks patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts to participate ...
FDA accepts for review Leo Pharmas BLA for tralokinumab to treat adults with atopic dermatitis.
FDA accepts for priority review an AstraZeneca supplemental NDA for Brilinta (ticagrelor) for reducing subsequent strokes in patients who experienced ...
FDA clears a Baxter International 510(k) for the AltaporeShape Bioactive Bone Graft, which is intended to enhance bone growth and help achieve fusion.
Federal Register notice: FDA sends to OMB a new information collection entitled Health Care Providers Understanding of Opioid Analgesic Abuse Deterren...
Federal Register notice: FDA sends to OMB a proposed information collection entitled Healthcare Provider Perception of Boxed Warning Information Surve...
The Microbiome Therapeutics Innovation Group petitions FDA to finalize a 2016 draft guidance to specify that sponsors and manufacturers of commercial-...
Politico reports that many drug companies have been raising prices during the coronavirus pandemic.