Tag: US Food and Drug Administration

Seagen gets FDA accelerated approval for tucatinib, trastuzumab combo for colorectal cancer

Raghuram Kadari- January 21, 2023

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

Raghuram Kadari- January 21, 2023

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

businessnewstoday- January 18, 2023

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

Raghuram Kadari- January 9, 2023

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

businessnewstoday- January 9, 2023

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

businessnewstoday- January 8, 2023

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

Raghuram Kadari- January 6, 2023

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

Raghuram Kadari- December 28, 2022

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

Raghuram Kadari- December 28, 2022

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

Gilead Sciences gets Sunlenca FDA approval for multi-drug resistant HIV

Raghuram Kadari- December 26, 2022

Sunlenca FDA approval : Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Sunlenca (lenacapavir), in combination with other ... Read More