FDA
The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.
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.
Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory review process to ensure novel therapies reach patients in a timely manner—because patients don’t have time to wait.
While the accelerated approval unlocks only a small market opportunity for Rocket Pharmaceuticals, it will give the biotech a chance to prepare for future product launches, according to Jefferies.
Avlayah is the first Hunter syndrome therapy approved to address the condition’s neurologic complications, according to Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research.
While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.
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.
At its peak, Imcivree’s sales in hypothalamic obesity could reach over $2 billion worldwide, according to analysts at Stifel.
With the approval of Wegovy HD, Novo Nordisk joins Johnson & Johnson, Boehringer Ingelheim and USAntibiotics as beneficiaries of the FDA’s Commissioner’s National Priority Voucher program, which aims to review products that align with certain national priorities in less than two months.
Sarepta Therapeutics says the FDA has agreed to review a regulatory package for Amondys 45 and Vyondys 53 after they failed a confirmatory trial, but whether the agency will agree to approve them is still unknown.
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