Browsing Tag
US Food and Drug Administration
333 posts
Zydus Lifesciences gets FDA approval for Ivermectin Cream, 1%
Zydus Lifesciences (previously called Cadila Healthcare) has secured final approval for antiparasitic ointment Ivermectin Cream, 1% from the…
Strides Pharma gets FDA approval for Cyclosporine Softgel Capsules
Strides Pharma Science said that its stepdown fully-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured approval…
Sarepta Therapeutics to seek FDA accelerated approval for SRP-9001 in DMD
Sarepta Therapeutics said that it plans to file a biologics license application (BLA) with the US Food and…
US biopharma company Incyte bags Opzelura FDA approval for vitiligo
Opzelura FDA approval for vitiligo : Incyte has secured approval for Opzelura (ruxolitinib) cream 1.5% from the US…
Granules pharmaceuticals gets six USFDA observations at Chantilly facility—what does it mean for its US growth plans?
Granules Pharmaceuticals gets six USFDA observations at its Chantilly, Virginia plant—what’s next for its US expansion strategy? Read the full analysis now.
Lantern Pharma gets FDA nod for Harmonic phase 2 clinical trial of LP-300
Lantern Pharma said that the US Food and Drug Administration (FDA) has authorized it to move ahead with…
Amryt gets FDA orphan drug designation for Mycapssa for carcinoid syndrome
Amryt, a commercial-stage biopharma company, has secured orphan drug designation for Mycapssa (octreotide capsules) from the US Food…
Prescient Therapeutics gets FDA orphan drug status for PTX-100 in PTCL
Prescient Therapeutics has secured the orphan drug designation for its PTX-100 compound from the US Food and Drug…
Dr. Reddy’s Laboratories launches antimuscarinic drug Toviaz generic in US
Dr. Reddy’s Laboratories has launched Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets in the US market following the approval…
Aura Biosciences gets FDA fast track status for belzupacap sarotalocan
Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration…