Browsing Tag
US Food and Drug Administration
348 posts
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…
Eisai, Biogen secure Leqembi FDA accelerated approval for Alzheimer’s disease
Eisai and Biogen have secured the approval of the US Food and Drug Administration (FDA) for their jointly…
FDA rejects Biocon Biologics BLA for Insulin-R product
Biocon Limited, an Indian biopharma company, said that its subsidiary Biocon Biologics has been issued a complete response…
Lupin secures US FDA approval for generic Fesoterodine Fumarate Extended-Release Tablets in overactive bladder treatment market
Lupin secures US FDA approval for generic Fesoterodine Fumarate ER tablets, entering a USD 177M overactive bladder market in the United States.
Vivos Therapeutics DNA oral device gets FDA nod for obstructive sleep apnea
Vivos Therapeutics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DNA oral device…
Genentech bags Lunsumio FDA approval for R/R follicular lymphoma
Lunsumio FDA approval : Genentech, a subsidiary of the Roche Group, has secured the approval of the US…