FDA and HHS says that the shelf-life of Eli Lillys bamlanivimab and etesevimab, for treating Covid-19, are being evaluated, and an update regarding a ...
FDA clears a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis.
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for Quick Turnaround Testing of Communication...
Federal Register notice: FDA makes available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs General Considerations.
Adagio Therapeutics pauses its EUA submission for adintrevimab, a Covid-19 treatment that is not effective against the BA.2 variant.
After submitting additional requested data, FDA extends by three months its review of a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and i...
Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Celiac Disease.
FDA grants InspectIR an emergency use authorization for the first Covid-19 diagnostic test that detects Covid-19 chemical compounds in breath samples.