Browsing Tag
US Food and Drug Administration
348 posts
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…
Tonix Pharmaceuticals gets FDA clearance for TNX-1900 phase 2 trial in chronic migraineurs
Tonix Pharmaceuticals is set to launch a phase 2 clinical trial of TNX-1900 (intranasal potentiated oxytocin) in migraine…
ReveraGen, Santhera get FDA grant for BMD trial of vamorolone
ReveraGen Biopharma and Santhera Pharmaceuticals have secured a $1.2 million grant for funding their clinical trial of vamorolone…
Caplin Point CRO division Amaris Clinicals clears FDA audit
Caplin Point Laboratories Limited said that its clinical research organization (CRO) division — Amaris Clinicals, which is located…
Zydus Cadila gets FDA approval for Apremilast Tablets
Zydus Cadila said that its subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and…
Glenmark Pharmaceuticals secures US FDA approval for Clindamycin Phosphate Foam, 1% generic
Glenmark Pharmaceuticals wins US FDA approval for its generic Clindamycin Phosphate Foam, 1%, expanding its US dermatology portfolio with a new acne treatment option.