Browsing Tag
US Food and Drug Administration
333 posts
Centessa Pharmaceuticals gets FDA orphan drug status for SerpinPC in hemophilia B
Centessa Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for SerpinPC in…
Zydus Lifesciences bags FDA approval for Cariprazine generic
Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary — Zydus Pharmaceuticals (USA) has secured final approval…
US FDA issues Form 483 to Alkem Laboratories for St. Louis manufacturing plant after pre-approval inspection
US FDA issues Form 483 to Alkem Laboratories’ St. Louis plant after a pre-approval inspection. Learn what this means for its US market plans.
Glenmark Pharmaceuticals gets OAI communication from US FDA for Goa plant
Glenmark Pharmaceuticals Limited said that the US Food and Drug Administration (FDA) has indicated that the inspection of…
Cipla receives six observations from FDA for Goa manufacturing facility
Cipla Ltd said that the US Food and Drug Administration (FDA) has concluded an inspection of the company’s…
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.