Tag: US FDA

FDA puts clinical hold on Selecta Biosciences SEL-302 phase 1/2 trial

businessnewstoday- November 27, 2021 0

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

businessnewstoday- November 24, 2021 0

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

businessnewstoday- November 23, 2021 0

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

businessnewstoday- November 13, 2021 0

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

businessnewstoday- October 9, 2021 0

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

businessnewstoday- September 27, 2021 0

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

businessnewstoday- September 26, 2021 0

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

businessnewstoday- September 26, 2021 0

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

businessnewstoday- September 21, 2021 0

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

businessnewstoday- September 19, 2021 0

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