Tag: US FDA
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 phase 1/2 clinical trial of SEL-302 gene ... Read More
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 patients after getting clearance from the US ... Read More
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 Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml ... Read More
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 pegcetacoplan to the US Food and Drug ... Read More
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 Benzoyl Peroxide Gel 0.3%/2.5%. A generic of ... Read More
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 in Becker muscular dystrophy (BMD) from the ... Read More
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 in Chennai, has wrapped up a virtual ... Read More
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 Drug Administration (FDA) to market Apremilast Tablets, ... Read More
Glenmark Pharmaceuticals gets FDA approval for Clindamycin Phosphate Foam
Glenmark Pharmaceuticals, an Indian pharma company, said that it has secured final approval for Clindamycin Phosphate Foam, 1% from the US Food and Drug Administration ... Read More
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 in the strengths of 5mg, 10mg, 20mg ... Read More
