Browsing Tag
FDA
293 posts
Apellis to submit NDA for intravitreal pegcetacoplan to FDA in H1 2022
Apellis Pharmaceuticals said that it is on track to submit a new drug application (NDA) for its intravitreal…
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…
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…
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…
Cipla associate Avenue Therapeutics fails to get FDA approval for IV tramadol
Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration…
Lupin secures FDA approval for generic Truvada, expanding HIV treatment and prevention portfolio in the US
Lupin secures US FDA approval for its generic version of Truvada, targeting HIV treatment and prevention. See what this means for the $2.1B US market.
Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic
Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets,…
Amgen secures FDA approval for LUMAKRAS in KRAS G12C-mutated lung cancer treatment
In a significant development for cancer treatment, Amgen has achieved accelerated approval from the U.S. Food and Drug…