Browsing Tag
US Food and Drug Administration
348 posts
Eagle Pharmaceuticals gets Pemfexy FDA approval for NSCLC
Eagle Pharmaceuticals has secured an additional indication for Pemfexy (pemetrexed injection) in the US, marking the fifth indication…
Gilead Sciences gets Sunlenca FDA approval for multi-drug resistant HIV
Sunlenca FDA approval : Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA)…
Genentech gets Actemra FDA approval for COVID-19 in hospitalized adults
Actemra FDA approval : Genentech, a subsidiary of Roche, has received the approval of the US Food and…
Abiomed gets FDA nod for Impella ECP pivotal heart pump in clinical trial
The US Food and Drug Administration (FDA) has cleared Abiomed to use the company’s version of Impella ECP…
Ferring bags Adstiladrin FDA approval in non-muscle invasive bladder cancer
Swiss biopharmaceutical company Ferring Pharmaceuticals has received approval for its Adstiladrin (nadofaragene firadenovec-vncg) gene therapy from the US…
Zydus Lifesciences gets FDA final approvals for Silodosin and Pregabalin capsules
Zydus Lifesciences (formerly known as Cadila Healthcare) has secured final approvals from the US Food and Drug Administration…
FDA grants EUA for Omicron-adapted Covid-19 vaccine for children below five
Pfizer and BioNTech have received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for their…
Alembic Pharmaceuticals gets FDA final approval for Desonide Cream, 0.05%
Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) of Desonide Cream, 0.05% from…
Rigel Pharmaceuticals gets Rezlidhia FDA approval for AML
Rigel Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its Rezlidhia (olutasidenib) capsules…
Zydus Lifesciences gets FDA approval for Estradiol Transdermal System
Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day,…