A failed July inspection of manufacturer Catalent Indiana LLC has delayed another U.S. FDA approval, the latest being that of Scholar Rock Inc.’s selective anti-latent myostatin antibody, apitegromab, which was expected to become the first therapy to enhance skeletal muscle in patients with spinal muscular atrophy.
Pfizer Inc. bounced back in a big way from a GLP-1 trip-up this spring by making known its plan to take over what Metsera Inc. CEO Whit Bernard has called the “scale-obsessed” obesity player that he steers. Pfizer has agreed to pay $47.50 each for all of Metsera’s outstanding shares.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Alvotech, Ars, Celltrion, Esperion, Fuji, Henlius, Idorsia, Incyte, Innovent, Ionis, Ipsen, Johnson & Johnson, Kalvista, Merck, NS, Nuvation Bio, Polyrizon, Organon, Otsuka, Roche, Torii, Verrica.
RSS
