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...
Bayer reports positive data from a second Phase 3 study that evaluated the safety and efficacy of finerenone versus placebo when added to standard of ...