News FDA knocks back Biogen's high-dose Spinraza Biogen's efforts to defend its SMA business have been dealt a setback after the FDA declined to approve a high-dose version of Spinraza.
News Manufacturing issues block FDA nod for Scholar Rock SMA drug Unresolved issues at a manufacturing plant operated by Novo Nordisk have led to a complete response letter for Scholar Rock's SMA drug apitegromab.
News Biogen buys CNS delivery specialist Alcyone Therapeutics Biogen buys Alcyone, bringing a partnered technology for delivery of antisense drugs into the central nervous system in-house.
News Biogen races into phase 3 with Spinraza follow-up Biogen is looking to the future of its spinal muscular atrophy (SMA) business, taking a candidate offering once-yearly dosing into phase 3.
News SMA treatment with Evrysdi 'could start prenatally' Should treatment of neurodegenerative disorder SMA with Roche's Evrysdi start even before birth? One case study suggests so.
News US/EU regulators start review of Biogen's high-dose Spinraza Biogen's new high-dose version of SMA drug Spinraza has started regulatory reviews - but can it help return the drug to growth?
Oncology ESMO25: On next-generation bispecifics, with Tadaaki Taniguc... At ESMO 2025 in Berlin, pharmaphorum spoke with Tadaaki Taniguchi, Chief Research & Development Officer at Astellas.
Sales & Marketing Sponsored How to meet your physicians where they are online A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.
