Browsing Tag
US FDA
379 posts
Can Aurobindo Pharma’s FDA EIR for its Telangana oral manufacturing facility boost US generics supply confidence?
Aurobindo Pharma secures a US FDA EIR with VAI status for its Telangana oral manufacturing facility, ensuring uninterrupted US generics supply.
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…
Medac resubmits treosulfan NDA to FDA, says Medexus Pharmaceuticals
Medexus Pharmaceuticals said that its strategic partner medac has resubmitted the new drug application (NDA) for treosulfan with…
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.
Marksans Pharma secures US FDA approval for multiple strengths of Pregabalin capsules in key neuropathic pain segment
Marksans Pharma wins US FDA approval for multi-strength Pregabalin capsules, targeting a USD 263M neuropathic pain market in the United States.
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…
Ikena Oncology gets FDA fast track designation for IK-930 in mesothelioma
Ikena Oncology has secured fast track designation for IK-930 from the US Food and Drug Administration in the…
Alkem Laboratories issued FDA Form 483 for St. Louis facility
Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration…