Browsing Tag
US Food and Drug Administration
333 posts
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.
Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets
Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) to market Vortioxetine Tablets…
Aurobindo subsidiary Eugia gets FDA approval for Cyclophosphamide Injection
Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug…
Zydus Cadila gets FDA approval for Revlimid generic Lenalidomide Capsules
Zydus Cadila said that the US Food and Drug Administration (FDA) has granted it tentative approval for Lenalidomide…
Lupin gets tentative FDA approval for Brivaracetam Tablets
Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA)…
Zydus Cadila secures US FDA approval for Mesalamine Extended-Release Capsules for ulcerative colitis remission maintenance
Zydus Cadila gets US FDA approval for Mesalamine Extended-Release Capsules 0.375g to maintain ulcerative colitis remission, strengthening its US generics portfolio.