FDA approves a Kyowa Kirin NDA for Nourianz (istradefylline) tablets as an add-on treatment for patients with Parkinsons disease experiencing off epis...
FDA releases the FDA-483 with 10 observations from an inspection at First Pharma Associates in Spokane, WA.
FDA warns Chinas Ningbo Pulisi Daily Chemical Products Co. about CGMP and other violations in its manufacturing of finished OTC drug products.
FDA approves Eli Lillys Taltz (ixekizumab) injection 80 mg/mL for treating adults with active ankylosing spondylitis.
Federal Register notice: FDA has announced a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to hear a laboratory research ov...
FDA plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of next month.
A new report from FDA examines pediatric labeling on orphan drugs that were approved from 4/1/1999 to 8/31/2018.
A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction drug Stendra (avanaf...