Browsing Tag
US Food and Drug Administration
348 posts
Marker Therapeutics gets FDA approval for MT-601 IND in r/r NHL
Marker Therapeutics said that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND)…
Vaxcyte gets FDA fast track designation for PCV candidate VAX-24
Vaxcyte has secured fast track designation for VAX-24, its 24-valent pneumococcal conjugate vaccine (PCV) candidate, from the US…
AstraZeneca, Daiichi Sankyo get Enhertu FDA approval for HER2-low metastatic breast cancer
Enhertu FDA approval : AstraZeneca and Daiichi Sankyo have secured approval for Enhertu (trastuzumab deruxtecan) from the US…
FDA inspection at Zydus Lifesciences’ Moraiya facility results in four Form 483 observations
US FDA issues four Form 483 observations at Zydus Lifesciences’ Moraiya plant; company commits to corrective action while confirming no data integrity concerns.
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…
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.