Due to overall survival concerns, TG Therapeutics withdraws its accelerated approval of Ukoniq (umbralisib), a PI3K inhibitor for treating adults with...
FDA issues Hiers Enterprises (dba Northwest Compounding Pharmacy) a Form FDA-483 after inspecting the firm in 11/2021.
FDA grants aTyr Pharma an orphan drug designation for efzofitimod and its use in treating systemic sclerosis.
FDA approves an Amneal Pharmaceuticals BLA for bevacizumab-maly, a biosimilar referencing Genentechs Avastin.
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 ...
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Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Celiac Disease.