FDA Review posts the Federal Register notices published during our annual end-of-year holiday break.
FDA Review posts product approval summaries for the week ending 1/4/2019.
FDA grants CRISPR Therapeutics and Vertex Pharmaceuticals a fast track designation for CTX001 for treating sickle cell disease.
FDA announces that former Flatiron Health chief medical officer Amy Abernethy will replace retiring Rachel Sherman as the agencys principal deputy com...
Torrent Pharmaceuticals expands an earlier recall from two lots of hypertension drug losartan potassium tablets USP to a total of 10 lots due to the d...
FDA accepts a Nabriva Therapeutics NDA and granted a priority review for Contepo (fosfomycin for injection) to treat complicated urinary tract infecti...
Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-sc...
Verrica Pharmaceuticals says it is planning an NDA submission in the second half of the year for VP-102 for treating molluscum contagiosum, a highly c...