Browsing Tag
US Food and Drug Administration
333 posts
Teva Pharmaceutical gets FDA approval for AUSTEDO XR for TD and HD
Teva Pharmaceutical Industries said that its US affiliate Teva Pharmaceuticals has secured approval for AUSTEDO XR (deutetrabenazine) extended-release…
Zydus Lifesciences gets FDA final approval for Rapamune generic – Sirolimus Tablets
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) for Sirolimus Tablets, 1…
GSK secures full Jemperli FDA approval for endometrial cancer treatment
Biopharma company GSK has secured the full approval of the US Food and Drug Administration (FDA) for its…
Gilead gets Trodelvy FDA approval for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Trodelvy (sacituzumab govitecan-hziy)…
GSK gets Jesduvroq FDA approval for anaemia of chronic kidney disease
GSK has secured the approval of the US Food and Drug Administration (FDA) for the company’s Jesduvroq (daprodustat)…
FDA approves Guardant360 CDx assay as companion diagnostic for Menarini’s ORSERDU for metastatic breast cancer
Guardant Health, an oncology company, has secured the approval of the US Food and Drug Administration (FDA) for…
Lilly gets Jaypirca FDA approval for mantle cell lymphoma
Loxo@Lilly, the oncology division of Eli Lilly and Company (Lilly), has secured the accelerated approval of the US…
Seagen gets FDA accelerated approval for tucatinib, trastuzumab combo for colorectal cancer
American biotechnology company Seagen (formerly Seattle Genetics) has received accelerated approval from the US Food and Drug Administration…
BeiGene gets Brukinsa FDA approval for chronic lymphocytic leukemia
BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib)…
Strides Pharma Science’s CDMO unit gets FDA EIR for Bengaluru facility
Strides Pharma Science said that its biologics arm Stelis Biopharma has secured an establishment inspection report (EIR) from…