Browsing Tag
US FDA
379 posts
Astellas hit by fatal event in ASPIRO clinical trial of AT132 in XLMTM
Astellas Pharma said that a participant in the ASPIRO clinical trial of AT132, who had developed a serious adverse event…
Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks
Welspun India Limited, a Mumbai-based home textile company, has secured 510 (k) clearance from the US Food and…
Zydus Cadila gets FDA tentative approval for Sitagliptin base tablets
Zydus Cadila said that its subsidiary has been granted tentative approval from the US Food and Drug Administration…
Lupin gets tentative FDA approval for Brivaracetam Tablets
Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA)…
Zydus Cadila secures US FDA approval for Mesalamine Extended-Release Capsules for ulcerative colitis remission maintenance
Zydus Cadila gets US FDA approval for Mesalamine Extended-Release Capsules 0.375g to maintain ulcerative colitis remission, strengthening its US generics portfolio.
Vivet’s VTX-801 gene therapy gets FDA fast track status in Wilson Disease
Vivet Therapeutics, a biotech company backed by Pfizer, has been given fast track designation by the US Food…
Pfizer gets FDA approval for tick-borne encephalitis vaccine TICOVAC
Pfizer has secured approval for its TICOVAC vaccine from the US Food and Drug Administration (FDA) for active…
Cipla gets FDA approval for generic version of Novartis’ Durezo
Cipla Limited said that it has secured final approval for its abbreviated new drug application (ANDA) for Difluprednate…
Lantern Pharma bags FDA orphan drug status for LP-184 in pancreatic cancer
Lantern Pharma has secured orphan drug designation for its small molecule drug candidate LP-184 from the US Food…
Octapharma gets Octagam 10% FDA approval for adult dermatomyositis
Octapharma USA has secured approval for Octagam 10% [Immune Globulin Intravenous (Human)] from the US Food and Drug…