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...
The DC federal court tosses a Jazz Pharmaceuticals suit against FDA over the agencys approval of Avadels narcolepsy drug Lumryz before the end of the ...
Federal Register notice: FDA makes available a final guidance entitled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms and a supplem...
FDA accepts for review a Shanghai Henlius Biotech and Organon BLA for their biosimilar of Amgens Prolia/Xgeva (denosumab).
FDA publishes the International Council for Harmonization M13A guidance on bioequivalence studies for immediate-release solid oral dosage drug forms.
