Browsing Tag
US Food and Drug Administration
333 posts
Eisai, Biogen secure Leqembi FDA accelerated approval for Alzheimer’s disease
Eisai and Biogen have secured the approval of the US Food and Drug Administration (FDA) for their jointly…
FDA rejects Biocon Biologics BLA for Insulin-R product
Biocon Limited, an Indian biopharma company, said that its subsidiary Biocon Biologics has been issued a complete response…
Lupin secures US FDA approval for generic Fesoterodine Fumarate Extended-Release Tablets in overactive bladder treatment market
Lupin secures US FDA approval for generic Fesoterodine Fumarate ER tablets, entering a USD 177M overactive bladder market in the United States.
Vivos Therapeutics DNA oral device gets FDA nod for obstructive sleep apnea
Vivos Therapeutics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DNA oral device…
Genentech bags Lunsumio FDA approval for R/R follicular lymphoma
Lunsumio FDA approval : Genentech, a subsidiary of the Roche Group, has secured the approval of the US…
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…