Browsing Tag
US FDA
379 posts
Amylyx Pharmaceuticals gets RELYVRIO FDA approval for ALS
RELYVRIO FDA approval for ALS : Amylyx Pharmaceuticals has secured approval for RELYVRIO (sodium phenylbutyrate and taurursodiol) from…
Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food…
Zydus Lifesciences gets tentative FDA approval for Sugammadex generic
Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for…
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.
Granules India gets FDA approval for Loperamide Hydrochloride and Simethicone Tablets
Granules India has secured approval for its abbreviated new drug application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets,…
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…
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.