Scholar Rock Resubmits Apitegromab BLA for SMA, Adds Second Fill-Finish Site; FDA Decision Eyed by Sept.

Scholar Rock (NASDAQ:SRRK) said it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug ...

Zenas BioPharma's Key Milestones And Market Context: Holding Through The BLA

Zenas BioPharma (ZBIO) faces a catalyst-rich 2026, with the key milestone being the planned BLA submission for obexelimab in ...

Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)

Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with ...

Sangamo targets summer 2026 for Fabry BLA submission while advancing neurology pipeline and partner talks

Q4 2025 Management View CEO Alexander Macrae stated that "Sangamo continued to make significant pipeline progress in 2025 and into the first quarter of '26. Set against a backdrop of regulatory and ...
Cure Today

BLA Has Been Submitted For Kidney Cancer Imaging PET Product Zircaix

Zircaix, a PET imaging drug for ccRCC, has been submitted for FDA approval and received Breakthrough designation, potentially allowing priority review. The phase 3 ZIRCON trial showed Zircaix's high ...
Cure Today

The FDA Accepts a BLA for RP1 Plus Opdivo in Advanced Melanoma

The FDA accepted a Priority Review BLA for RP1 and Opdivo in advanced melanoma, with a PDUFA date of July 22, 2025. The BLA is supported by IGNYTE trial data, focusing on patients with anti-PD-1 ...