AstraZeneca provides four comments to the FDA docket on considerations for generative artificial intelligence/machine learning over a medical devices ...
GE HealthCare subsidiary Datex-Ohmeda recalls its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions.
UCB says its investigational Alzheimers drug bepranemab missed the primary endpoint in a Phase 2a trial but hit secondary endpoints in some patient su...
Verastem Oncology completes a rolling NDA submission for the combination of avutometinib and defactinib for adults with recurrent KRAS mutant low-grad...
FDA publishes the International Council for Harmonization M13A guidance on bioequivalence studies for immediate-release solid oral dosage drug forms.
Sage Therapeutics and Biogen decide to not seek an expanded use (major depressive disorder) for postpartum depression drug Zurzuvae (zuranolone).
Rep. Abigail Spanberger asks FDA and DEA for additional information on their efforts to address shortages of ADHD drugs.
FDA posts the establishment inspection report with seven observations from a 2023 inspection at a Boehringer Ingelheim drug manufacturing facility in ...
