Critically ill Covid-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said on Sunday.
The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Results of a pivotal phase III study of Supernus Pharmaceuticals’ SPN-812 (viloxazine extended-release capsules) were published in the journal Clinical Therapeutics.
The U.S. Food and Drug Administration issued a new template for clinical test developers that is designed to assist these companies in developing and submitting emergency use authorization (EUA) for Covid-19 tests that can be performed at home or in other settings besides laboratories.
Bristol Myers Squibb and bluebird bio announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.
The U.S. House of Representatives approved a $3.2 billion budget proposal for the U.S. Food and Drug Administration that will boost the regulatory agency’s abilities to approve new medicines and medical devices, as well as protect the nation’s food supplies.
European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in wrangles over price, payment method and potential liability costs, three EU officials told Reuters.
The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Tecartus (brexucabtagene autoleucel, formerly KTE-X19) as the first approved chimeric antigen receptor T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The U.S. Food and Drug Administration gave the green light to AstraZeneca for a new chronic obstructive pulmonary disease (COPD) treatment, Breztri Aerosphere.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the expanded approval of Kyowa Kirin Co. Ltd.’s Crysvita (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphatemia.
