Browsing Tag
US Food and Drug Administration
333 posts
Gilead gets Trodelvy FDA priority review for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences said that Trodelvy (sacituzumab govitecan-hziy) has been granted priority review from the US Food and Drug…
Lilly gets FDA fast track designation for tirzepatide in obesity
Eli Lilly and Company (Lilly) has been granted fast track designation for tirzepatide from the US Food and…
Zydus Lifesciences gets FDA final approval for Brivaracetam generic
Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has bagged final approval to…
Cue Biopharma gets FDA fast track status for CUE-101 in HPV16+ R/M HNSCC
Cue Biopharma has been granted fast track designation for CUE-101 from the US Food and Drug Administration (FDA)…
Zydus Lifesciences gets final FDA approval for Mirabegron generic
Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has secured final approval from…
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…