Genmab A/S and Seagen Inc. announced that the U.S. Food and Drug Administration granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The U.S. Food and Drug Administration on Sept. 20 approved South Korean drugmaker Samsung Bioepis Co. Ltd. and Biogen Inc.’s biosimilar rival to Roche Holding AG’s blockbuster eye medicine Lucentis.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).
U.S. lawmakers requested data and documents from the Food and Drug Administration related to the regulatory agency’s accelerated approval of Biogen Inc.’s new Alzheimer’s drug, mounting further pressure on the FDA that has come under fire for clearing Aduhelm.
Dr. Reddy’s Laboratories Ltd. along with the company’s subsidiaries announced that Reddy-Lenalidomide, a generic equivalent to Revlimid (lenalidomide) capsules, was approved by Health Canada and launched in the Canadian market.
BeiGene Ltd.’s Brukinsa (zanubrutinib) received approval from the U.S. Food and Drug Administration for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
The U.S. Food and Drug Administration greenlit Janssen’s long-acting, twice-per-year schizophrenia drug Invega Hafyera (paliperidone palmitate six-month).
The U.S. Food and Drug Administration approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for children 1 year and older who have growth failure from inadequate secretion of endogenous growth hormone (GH).
The Food and Drug Administration on Aug. 23 approved Cara Therapeutics’ drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making Korsuva the first therapy for the ailment in the United States.
