FDA
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
FEATURED STORIES
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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Merck’s Winrevair is the second PAH drug to get the FDA’s green light in the past week, following Johnson & Johnson’s Opsynvi, which won approval on Friday.
Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.
Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.
Duvyzat, which will be sold in the U.S. by ITF Therapeutics, joins a growing market that includes recently approved gene therapy Elevidys and corticosteroid Agamree.
Months after Johnson & Johnson turned its back on the hypertension treatment Tryvio, Idorsia has secured the FDA’s nod for the endothelin receptor blocker.
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.