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 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 ...
Monthly Prescribing Reference

Moderna Withdraws BLA for Flu/COVID-19 Combo Vaccine Candidate

The BLA for mRNA-1083 will be resubmitted later this year once vaccine efficacy data from an ongoing phase 3 trial assessing mRNA-1010 are available. Moderna has withdrawn the Biologics License ...
PharmiWeb

Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic Malignancies

New PDUFA Target Action Date of July 6, 2026 allows FDA additional time to complete its reviewMENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a late-stage biotechnology company committed to ...

Taysha outlines 2026 BLA submission path for TSHA-102 as pivotal trial enrollment advances

Management indicated the pivotal and ASPIRE trials are "on track to complete dosing in the second quarter of 2026." The company expects to initiate BLA-enabling process performance qualification (PPQ) ...