Browsing Tag
US Food and Drug Administration
348 posts
AbbVie bags RINVOQ FDA approval for nr-axSpA in adults
RINVOQ FDA approval for nr-axSpA : AbbVie has bagged approval for its selective JAK inhibitor RINVOQ (upadacitinib 15…
Vanda Pharmaceuticals gets FDA orphan drug status for VPO-227 in cholera
Vanda Pharmaceuticals has secured orphan drug designation for VPO-227 from the US Food and Drug Administration (FDA) for…
Zydus Lifesciences gets FDA tentative approval for Valbenazine Capsules
Zydus Lifesciences (previously called Cadila Healthcare) said that its subsidiary Zydus Worldwide DMCC has been given tentative approval…
Can Unichem Laboratories’ FDA approval for generic Dilantin boost its US epilepsy drug portfolio?
Unichem Laboratories wins US FDA approval for its generic Dilantin capsules to treat seizures, expanding its US neurology portfolio.
Biomea Fusion to take BMF-219 into clinical trials for KRAS solid tumors
Biomea Fusion is all set to take BMF-219 into clinical trials in patients having unresectable, locally advanced, or…
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…