Scholar Rock drops Novo's Indiana plant from apitegromab's FDA filing after a new
Massachusetts biotech Scholar Rock said it’s pulling an embattled Indiana-based manufacturing site from its application for a potential new spinal muscular atrophy drug, after the …
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Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
Scholar Rock Overcomes Manufacturing Hurdle to Keep Lead Drug FDA Review on Schedule - Scholar Rock Holdi
Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date
In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment
ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
Epicrispr lands $90M to advance epigenetic editing drug for rare muscle disease
Scholar Rock has shed Novo Nordisk’s troubled Cata | Scholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a…
Scholar Rock shifts its FDA review for SMA treatment apitegromab to a secondary facility, keeping the September 30 approval date…
Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to…
Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing…
Scribe markets its Nasdaq IPO at a $14 midpoint for ~$96M net proceeds; Scholar Rock's apitegromab awaits an FDA call on Novo…
The FDA has rejected a radiopharmaceutical therapy due to manufacturing issues, halting what would have been a competitor for…
