Browsing Tag
US Food and Drug Administration
348 posts
Harrow Health announces IHEEZO FDA approval for ocular surface anesthesia
IHEEZO FDA approval : Harrow Health, a Nasdaq-listed eyecare pharmaceutical company, and Sintetica have secured approval for IHEEZO…
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 launches Revlimid generic – Lenalidomide Capsules in US
Indian pharma company Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited has launched Lenalidomide Capsules, a generic…
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.
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…