Tag: FDA

Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks

businessnewstoday- September 6, 2021 0

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

businessnewstoday- September 6, 2021 0

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

Lantern Pharma bags FDA orphan drug status for LP-184 in pancreatic cancer

businessnewstoday- August 11, 2021 0

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

Octapharma gets Octagam 10% FDA approval for adult dermatomyositis

businessnewstoday- July 20, 2021 0

Octapharma USA has secured approval for Octagam 10% from the US Food and Drug Administration (FDA) for the treatment of adult dermatomyositis. The company, which ... Read More

Alkem Laboratories gets Form 483 from US FDA for St. Louis plant

businessnewstoday- June 19, 2021 0

Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations. Form 483 are given ... Read More

Cipla associate Avenue Therapeutics fails to get FDA approval for IV tramadol

businessnewstoday- June 15, 2021 0

Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration (FDA) for IV tramadol as an alternative ... Read More

Lupin Limited gets FDA nod for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

businessnewstoday- June 7, 2021 0

Lupin Limited (Lupin) said it has secured approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the US Food and Drug ... Read More

Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

businessnewstoday- June 4, 2021 0

Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg. The Indian ... Read More

LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC

businessnewstoday- May 29, 2021 0

LUMAKRAS FDA approval : Amgen has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a ... Read More

Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets

businessnewstoday- May 29, 2021 0

Cadila Healthcare (also known as Zydus Cadila) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Fluphenazine ... Read More