Browsing Tag
US Food and Drug Administration
333 posts
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…
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…
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…
Dialysis care boost: Lupin Limited wins USFDA green light for Renvela-equivalent packets, targeting a $51.7m market
Find out how Lupin Limited’s USFDA approval for Sevelamer Carbonate oral suspension could reshape U.S. dialysis procurement and patient access today.
Ocugen secures FDA clearance to begin OCU400 gene therapy trial: What this means for patients with retinitis pigmentosa
Find out how Ocugen’s FDA-approved OCU400 trial is shaping the future of gene therapy for retinitis pigmentosa. Read the full story today.
FDA puts clinical hold on Selecta Biosciences SEL-302 phase 1/2 trial
Selecta Biosciences said that the US Food and Drug Administration (FDA) has imposed a clinical hold on its…