Tag: US FDA
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
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
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
Genentech gets Actemra FDA approval for COVID-19 in hospitalized adults
Actemra FDA approval : Genentech, a subsidiary of Roche, has received the approval of the US Food and Drug Administration (FDA) for Actemra (tocilizumab) intravenous ... Read More
Abiomed gets FDA nod for Impella ECP pivotal heart pump in clinical trial
The US Food and Drug Administration (FDA) has cleared Abiomed to use the company’s version of Impella ECP pivotal heart pump in pivotal clinical trial. ... Read More
Ferring bags Adstiladrin FDA approval in non-muscle invasive bladder cancer
Swiss biopharmaceutical company Ferring Pharmaceuticals has received approval for its Adstiladrin (nadofaragene firadenovec-vncg) gene therapy from the US Food and Drug Administration (FDA) for the treatment ... Read More
