Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2…

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that it has submitted a Biologics ...
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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, ...
Seeking Alpha

Axogen raises 2025 revenue growth target to at least 17% as BLA approval nears

The company raised its full-year 2025 revenue growth guidance to "at least 17% or revenue of at least $219 million." Gross margin guidance remains in the "range of 73% to 75%, inclusive of onetime ...
Pharmaceutical Technology on MSN

Atara receives FDA complete response letter for Ebvallo BLA application

The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
Targeted Oncology

FDA Receives BLA for Ivonescimab in EGFR+ NSCLC

The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
Business Insider

BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease

MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX) , a ...
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 ...
Nasdaq

Denali: FDA To Review BLA Seeking Accelerated Approval For Tividenofusp Alfa

(RTTNews) - Denali Therapeutics (DNLI) announced that the FDA has accepted for review the Biologics License Application seeking accelerated approval for tividenofusp alfa for the treatment of Hunter ...