Browsing Tag
US FDA
379 posts
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 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…
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…
Alembic Pharmaceuticals gets FDA approval for Toviaz generic
Alembic Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for…
ALX Oncology’s evorpacept gets FDA ODD for gastric cancer and gastroesophageal junction cancer
ALX Oncology said that its CD47 blocker evorpacept has secured orphan drug designation (ODD) from the US Food…
Glenmark Pharmaceuticals bags FDA approval for Metronidazole Vaginal Gel
Glenmark Pharmaceuticals said that it has bagged final approval from the US States Food and Drug Administration (FDA)…
Lannett gets FDA nod for clinical trial of biosimilar insulin glargine
Lannett Company has been given clearance from the US Food and Drug Administration (FDA) to proceed with a…
Gilead Sciences gets Veklury FDA approval for non-hospitalized Covid-19 patients
Gilead Sciences has secured expedited approval from the US Food and Drug Administration (FDA) for its nucleotide analog…
Zydus Cadila gets FDA approval to market Vigabatrin Tablets 500mg
Zydus (Cadila Healthcare) has secured final approval from the US Food and Drug Administration (FDA) to market Vigabatrin…