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 Food and Drug Administration (FDA) for Jaypirca ... Read More
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 (FDA) for the company’s oral drug Tukysa ... Read More
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) for the treatment of adult patients with ... Read More
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 the US Food and Drug Administration (FDA) ... Read More
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 developed Leqembi (lecanemab-irmb) under the accelerated approval ... Read More
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 letter (CRL) from the US Food and ... Read More
Lupin gets approval for overactive bladder syndrome drug generic
Lupin Limited has secured approval for its abbreviated new drug application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg from the United ... Read More
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 indicated for obstructive sleep apnea (OSA) treatment. ... Read More
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 Food and Drug Administration (FDA) for Lunsumio ... Read More
Eagle Pharmaceuticals gets Pemfexy FDA approval for NSCLC
Eagle Pharmaceuticals has secured an additional indication for Pemfexy (pemetrexed injection) in the US, marking the fifth indication for the intravenous medication. Pemfexy in combination ... Read More