An advisory panel to the U.S. FDA said benefits of Amgen Inc.’s osteoporosis treatment for postmenopausal women at high risk for fracture outweighed the monthly injection’s risks.
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.
Spark Therapeutics Inc.’s experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded, paving the way for the first U.S. gene therapy for an inherited disease.
A U.S. Food and Drug Administration advisory panel voted 11-0 that the safety and efficacy of GlaxoSmithKline’s Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.
FDA Advisory Committee Unanimously Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab
Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee recommended approval of the companies’ proposed biosimilar trastuzumab.
A U.S. Food and Drug Administration advisory panel unanimously recommended approval of Novartis AG’s CAR-T therapeutic, CTL019 (tisagenlecleucel), for B-cell acute lymphoblastic leukemia.
The U.S. FDA Oncologic Drugs Advisory Committee recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.
Valeant Pharmaceuticals International Inc.’s experimental drug to treat the skin disorder psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide.
Merck & Co.’s experimental drug to treat the most common cause of hospital-associated infectious diarrhea warrants approval, an advisory panel to the U.S. FDA said.
A U.S. advisory panel recommended approval of Pfizer Inc’s long-acting opioid painkiller Troxyca ER, saying it dulls pain and its design could deter abuse by addicts in search of a quick high.