Browsing Tag
US FDA
379 posts
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…
Alembic Pharmaceuticals gets FDA approval for Formoterol Fumarate Inhalation Solution
Alembic Pharmaceuticals said that it has secured final approval from the US Food and Drug Administration (FDA) for…
Apellis to submit NDA for intravitreal pegcetacoplan to FDA in H1 2022
Apellis Pharmaceuticals said that it is on track to submit a new drug application (NDA) for its intravitreal…
Zydus Cadila gets FDA tentative approval for acne treatment generic
Zydus Cadila has secured tentative approval from the US Food and Drug Administration (FDA) for marketing Adapalene and…
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…