Tag: US FDA
Strides Pharma Science gets FDA approval for Colchicine Tablets generic
Strides Pharma Science Limited said that its Singapore-based stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited has secured approval for Colchicine Tablets USP, 0.6 ... Read More
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 the treatment of certain patient population with ... Read More
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 the US Food and Drug Administration (FDA) ... Read More
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 (sNDA) for its isolator-based drug manufacturing facility ... Read More
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 treatment of hemolytic anemia in adult patients ... Read More
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 (sNDA) to expand the indication of SOLOSEC ... Read More
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 supplemental biologics license application (sBLA) for Breyanzi ... Read More
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 Drug Administration (FDA) to market Roflumilast Tablets ... Read More
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 (FDA) for bebtelovimab for the treatment of ... Read More
Pulse Biosciences fails to get FDA’s expanded approval for CellFX System
The US Food and Drug Administration (FDA) has rejected an application of Pulse Biosciences is seeking expansion to the current labeling of CellFX System to ... Read More
