Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both ...

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports: - a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in ...