Browsing Tag
US Food and Drug Administration
333 posts
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 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…
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…
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…
Natco Pharma gets FDA approval for Lenalidomide Capsules
Natco Pharma has secured the final approval from the US Food and Drug Administration (FDA) of its abbreviated…
Unichem Laboratories gets FDA approval for Amitriptyline HCl Tablets generic
Unichem Laboratories, an Indian specialty pharma company, said that it has secured abbreviated new drug application (ANDA) approval…
Can Alembic Pharmaceuticals challenge Latuda with its FDA-approved Lurasidone Hydrochloride Tablets?
Find out how Alembic Pharmaceuticals’ FDA approval for Lurasidone Hydrochloride Tablets positions the drugmaker in the $3.7B bipolar depression market.
Transcenta gets US FDA clearance for launching phase 1 trial of TST005
Transcenta has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug…
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…