AxoGen Conference: AVANCE BLA Approval, Debt Paydown Fuel 2026 Growth Target of 18%+

AxoGen (NASDAQ:AXGN) executives outlined a year of accelerating commercial momentum, recent balance sheet improvements, and ...

AxoGen Says BLA Approval Secures Avance Use, Boosts Coverage Talks and Reimbursement Momentum

AxoGen (NASDAQ:AXGN) executives said a newly secured Biologics License Application (BLA) approval has preserved the company’s ability to serve patients across a broad range of peripheral nerve repair ...
Seeking Alpha

INOVIO Completes Rolling BLA Submission Seeking Accelerated Approval for INO-3107 as a Treatment for RRP in Adults

Recurrent respiratory papillomatosis (RRP) is a rare HPV-related disease of the respiratory tract with significant unmet need INO-3107 previously received Orphan Drug and Breakthrough Therapy ...
Business Insider

Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s review of available clinical data from open label study FDA written ...
abc27

IASO Bio Announces BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of Relapsed or Refractory Multiple Myeloma

SHANGHAI and NANJING, China and PLEASANTON, Calif., Nov. 27, 2025 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, ...
Nasdaq

Atara Biotherapeutics Stock Falls After FDA CRL On EBVALLO BLA

(RTTNews) - Atara Biotherapeutics Inc. (ATRA) announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of EBVALLO ...