The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Amgen and UCB announced that the U.S. FDA approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
The FDA approved ViiV’s Dovato as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for treating HIV-1 infection in adults with no antiretroviral treatment history and no known resistance to either DTG or 3TC.
The U.S. Food and Drug Administration approved ADMA Biologics’ Asceniv to treat primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents.
The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.
EMD Serono, a unit of Merck KGaA, announced that the U.S. FDA approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis and active secondary progressive disease.
Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.
The FDA – looking to ease shortages triggered by several manufacturers recalling the blood pressure medicine valsartan over possible cancer risk – approved a new generic version of the drug.
The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche AG’s blockbuster breast cancer treatment Herceptin.
The U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.
