Breaking with its long-held, oft-recited mantra that observational studies are great for generating hypotheses but not as evidence for approval, the U.S. FDA is initiating the approval of leucovorin calcium tablets for patients with cerebral folate deficiency, a neurological condition that affects folate transfer into the brain.
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.
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