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Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Celiac Disease.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.
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products In...
Federal Register notice: FDA makes available a final guidance on Compounding Animal Drugs from Bulk Drug Substances.
Pfizer says it and BioNTech will request an FDA emergency use authorization for a Covid vaccine booster shot for children ages 5-11.
FDA publishes a guidance to help sponsors submit bioavailability information for specified drug products in INDs and NDAs.