Browsing Tag
US Food and Drug Administration
333 posts
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…
August 14, 2021
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…
August 12, 2021
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…
August 11, 2021
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…
July 20, 2021
Unichem Laboratories gets FDA approval for Sitagliptin Tablets
Unichem Laboratories Limited said that it has secured tentative approval for abbreviated new drug application (ANDA) of Sitagliptin…
July 10, 2021
Jazz Pharmaceuticals gets Rylaze FDA approval for ALL and LBL
Rylaze FDA approval : Jazz Pharmaceuticals has secured approval for its leukemia drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn…
July 3, 2021
Lupin Limited gets FDA tentative approval for HIV drug cocktail TLD
Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new…
July 1, 2021
Zydus Cadila gets FDA nod for chemotherapy drug Pemetrexed generic
Cadila Healthcare (also known as Zydus Cadila) said that it has secured tentative approval from the US Food…
June 28, 2021
Natco Pharma gets FDA approval for Carfilzomib Vials ANDA
Natco Pharma Limited said that its marketing partner – Breckenridge Pharmaceutical Inc. (BPI), has secured approval from the…
June 20, 2021
Alkem Laboratories gets Form 483 from US FDA for St. Louis plant
Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company…
June 19, 2021