Tag: US FDA
Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets
Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) to market Vortioxetine Tablets in the strengths of 5mg, 10mg, 20mg ... Read More
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 earlier this month, has passed away. The ... Read More
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 Drug Administration (FDA) for its 3 Ply ... Read More
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 (FDA) for its new drug application (NDA) ... Read More
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) for its abbreviated new drug application (ANDA) ... Read More
Zydus Cadila gets FDA approval for Mesalamine Extended-Release Capsules
Zydus Cadila said that it has secured final approval from the US Food and Drug Administration (FDA) to market Mesalamine Extended-Release Capsules in the strength ... Read More
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 and Drug Administration for its gene therapy ... Read More
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 immunization against tick-borne encephalitis (TBE) in individuals ... Read More
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 Ophthalmic Emulsion 0.05% from the US Food ... Read More
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 and Drug Administration (FDA) for the treatment ... Read More
