The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s oral heart disease drug, making Camzyos (mavacamten) the first cardiac myosin inhibitor to be permitted for use in the country.
First Antibiotic With New Mechanism of Action Approved in Almost 20 Years
Antibiotics, Approvals, Community-Acquired Bacterial Pneumonia (CABP), Emergency Departments, Emergency Rooms, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, Priority Review, U.S. Centers for Disease Control and Prevention, Wholesale Acquisition CostThe U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position.