Browsing Tag
US Food and Drug Administration
348 posts
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
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…
June 15, 2021
Lupin Limited gets FDA warning letter for Lupin Somerset site
Indian pharma company Lupin Limited said that it has been issued a warning letter from the US Food…
June 14, 2021
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,…
June 4, 2021
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…
May 29, 2021
Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets
Cadila Healthcare (also known as Zydus Cadila) said that it has secured final approval from the US Food…
May 29, 2021