The FDA granted accelerated approval to Replimune's melanoma drug Tudriqev on Thursday, ending a regulatory saga that saw the therapy rejected twice. The oncolytic viral treatment, approved for advanced melanoma patients who failed prior immunotherapy, represents a hard-fought win for the Massachusetts biotech and desperate patients with limited options.

Vital Signs

• $450,000 — price per course of therapy before rebates and discounts
• 24% — objective response...