FDA
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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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Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace,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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Speaking on Bloomberg TV on Monday, FDA Commissioner Marty Makary contradicted recent reporting that suggested the agency was planning to add a black box label—its most serious warning—to COVID-19 vaccines.
Analysts at Jefferies called the approval “highly significant,” estimating it could add $2 billion to $3 billion to peak Enhertu sales.
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
The FDA had previously turned back the heart rhythm nasal spray twice, once in late 2023 with a refusal to file letter and again in March this year, when it flagged manufacturing issues.
The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.
Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.