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Tolebrutinib, which the FDA recently turned back due to safety concerns, received a positive recommendation that positions the therapy for its first regulatory approval.

Lilly shares dipped, and Novo’s climbed, as Foundayo’s early trajectory diverged from that of oral Wegovy. Elsewhere, Regeneron inked a drug price deal and two companies announced leadership changes.

Otarmeni, now cleared to treat a rare, inherited kind of hearing loss, is the first gene therapy cleared under the FDA’s “national priority” voucher program and will be offered to eligible patients…