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Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace,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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The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.
The FDA greenlit AstraZeneca’s tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
The FDA approved Alnylam’s Oxlumo for an expanded indication, rare disease PH1, with the label to include patients with the most severe kidney impairment.
The biopharma world - and markets - spent Thursday evening reacting after the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s Relyvrio.
The FDA has approved Regeneron and Sanofi’s Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, making it the first drug approved for this indication.
The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.
The FDA approved bluebird bio’s lentiviral vector (LVV) eli-cel Friday as the first therapy to slow the progression of neurologic dysfunction in juvenile boys with early, active CALD.