Tag: US Food and Drug Administration

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

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

Aurobindo subsidiary Eugia gets FDA approval for Cyclophosphamide Injection

businessnewstoday- August 28, 2021 0

Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application ... Read More

Zydus Cadila gets FDA approval for Revlimid generic Lenalidomide Capsules

businessnewstoday- August 22, 2021 0

Zydus Cadila said that the US Food and Drug Administration (FDA) has granted it tentative approval for Lenalidomide Capsules, a generic version of Celgene Corporation’s ... Read More

Lupin gets tentative FDA approval for Brivaracetam Tablets

businessnewstoday- August 16, 2021 0

Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) ... Read More