Novo Nordisk recalls 1,468 product samples due to improper storage.
FDA releases for public comment proposed revisions to an International Council for Harmonization guideline on elemental impurities.
FDA grants breakthrough device designation to Avenda Healths prostate cancer artificial intelligence-enabled focal therapy system.
AstraZeneca submits a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma.
FDA publishes an International Council for Harmonization final guidance on technical and regulatory considerations for postapproval management of drug...
Federal Register notice: FDA seeks comments on an information collection revision entitled Registration of Producers of Drugs and Listing of Drugs in ...
FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid-19 vaccines and their use in the pediatric p...
The Multidisciplinary Association for Psychedelic Studies asks FDA to remove a clinical hold against a study designed to assess the psychological effe...