Browsing Tag
US Food and Drug Administration
348 posts
Lupin secures FDA approval to launch generic vigabatrin oral solution in the US market
Lupin secures US FDA approval for generic vigabatrin oral solution, a $275M epilepsy drug, boosting its US generics and neurology portfolio.
Harpoon Therapeutics gets FDA fast track status for HPN217 in RRMM
Harpoon Therapeutics has bagged fast track designation for HPN217 from the US Food and Drug Administration (FDA) for…
Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate
Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from…
Lantheus gets FDA approval for drug manufacturing facility in Billerica
Lantheus Holdings has secured approval from the US Food and Drug Administration (FDA) for the supplemental drug application…
Agios Pharmaceuticals gets PYRUKYND FDA approval for hemolytic anemia
Agios Pharmaceuticals has secured approval for PYRUKYND (mitapivat) from the US Food and Drug Administration (FDA) for the…
Lupin Pharmaceuticals gets FDA approval for SOLOSEC sNDA
Lupin Pharmaceuticals has secured approval from the US Food and Drug Administration for its supplemental new drug application…
Bristol Myers Squibb gets FDA priority review for Breyanzi sBLA
Bristol Myers Squibb (BMS) has secured priority review from the US Food and Drug Administration (FDA) for its…
Zydus gets FDA approval for COPD drug Roflumilast Tablets
Zydus Group said that its subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and…
Lilly, US govt sign deal for 600,000 doses of Covid-19 drug bebtelovimab
Eli Lilly and Company (Lilly) has signed a deal worth at least $720 million with the US government…
Lilly gets FDA EUA for bebtelovimab in mild-to-moderate Covid-19
Eli Lilly and Company (Lilly) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration…