The U.S. Food and Drug Administration expanded the emergency use authorization of Regeneron Pharmaceuticals Inc.’s Covid-19 antibody cocktail, enabling the combo therapy’s use as a preventive treatment for the illness in certain people.
The U.S. Food and Drug Administration rejected Ardelyx Inc.’s chronic kidney disease drug tenapanor by issuing a Complete Response Letter.
Biogen Inc. and partner Eisai Co. Ltd. on July 29 revealed the design of an upcoming study of their controversial Alzheimer’s treatment, Aduhelm.
The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The U.S. health regulator expanded the emergency use authorization for Eli Lilly’s baricitinib for Covid-19, saying the arthritis medicine could now be used without taking Gilead’s drug remdesivir along with the product.
The U.S. Food and Drug Administration approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product, which is indicated to control high blood sugar in adults with Type 2 diabetes as well as adults and pediatric patients with Type 1 diabetes.
Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced July 29 the company’s BiovitalsHF solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration.
After an earlier rejection from the U.S. Food and Drug Administration, Merck’s vaunted checkpoint inhibitor Keytruda won approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer.
Moderna Inc. is in talks with U.S. regulators to expand the size of an ongoing trial testing the company’s Covid-19 vaccines in children aged between 5 and 11 years, the drugmaker said on July 26.
Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.