Tag: FDA
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, 300 mg, and 450 mg. The Indian ... Read More
LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC
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
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
Alembic Pharmaceuticals gets FDA final approval for Doxepin Hydrochloride Capsules
Alembic Pharmaceuticals announces USFDA Final Approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. Alembic Pharmaceuticals has ... Read More
BMS, bluebird bio bag Abecma FDA approval for multiple myeloma in adults
Abecma FDA approval : Bristol Myers Squibb (BMS) and bluebird bio have secured approval from the US Food and Drug Administration (FDA) for Abecma (idecabtagene ... Read More
J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization
Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for Ad26.COV2.S, a single-dose COVID-19 vaccine ... Read More
FDA authorizes emergency use of Janssen COVID-19 Vaccine
The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine - Ad26.COV2.S manufactured by Johnson & ... Read More
G1 Therapeutics gets Cosela FDA approval to reduce chemotherapy-induced bone marrow suppression
G1 Therapeutics has bagged approval for Cosela (trilaciclib) from the US Food and Drug Administration (FDA) for reducing bone marrow suppression caused by chemotherapy. Cosela ... Read More
US FDA approves Opdivo, Cabometyx combo for advanced renal cell carcinoma
The US Food and Drug Administration (FDA) has approved the combination of Bristol Myers Squibb’ Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib) as a first line ... Read More
Janssen secures DARZALEX FASPRO FDA approval for AL amyloidosis
DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug ... Read More