The FDA has approved a supplemental new drug application (sNDA) to expand the label on mavacamten (Camzyos) to include data from the Phase 3 VALOR HCM study. The study evaluated mavacamten in patients with symptomatic hypertrophic obstructive cardiomyopathy (HCM) eligible for septal reduction therapy (SRT) and with New York Heart Association (NYHA) Class 3-4 or … Read more
Adalimumab, sold under the brand name Humira, has long been one of the best-selling drugs in the world. But its 20-year period without competition has ended, and despite its best efforts to delay its arrival, drugmaker AbbVie now faces increasing competition from biosimilars entering the market. But a biosimilar about to be launched could be … Read more
Paving the way for the launch of the first over-the-counter erectile dysfunction gel in the United States, Futura Medical’s Eroxon has received marketing authorization from the Food and Drug Administration (FDA), CNN reported. The announcement was made on Monday by the pharmaceutical company. The product has been around for some time in the UK and … Read more