Business, energy, technology, markets and global industry news from Business News Today

Catalent Indiana

PharmaDeviceNews Catalent Indiana
Scholar Rock has preserved apitegromab’s September 30 FDA target date by removing the OAI-classified Catalent Indiana facility from its US filing and shifting to an alternate manufacturer, while preparing to resubmit the European application. Representative image.
Pharma & Biotech

One fill-finish plant exits, another takes over as Scholar Rock keeps apitegromab on track for FDA review

Scholar Rock has removed the OAI-classified Catalent Indiana facility from apitegromab’s US filing, preserving its September 30 FDA target through an alternate manufacturer while withdrawing and preparing to resubmit the European application.

Read More
Scholar Rock’s apitegromab remains under FDA review for spinal muscular atrophy as the company shifts to a second U.S. fill-finish facility ahead of the September 30, 2026 regulatory decision. Representative image.
Pharma & Biotech

Apitegromab survives another manufacturing hurdle: Can Scholar Rock still secure FDA approval by September 30?

Scholar Rock shifts apitegromab’s FDA review to a second fill-finish site as its September 30 SMA decision date remains on track.

Read More