Benzinga.com

FDA Pushes Back Axogen Avance Nerve Graft Decision By 3 Months

The U.S. Food and Drug Administration (FDA) on Monday extended the Prescription Drug User Fee Act (PDUFA) goal date for Axogen Inc.’s (NASDAQ:AXGN) Biologics License Application (BLA) for Avance Nerve ...
JD Supra

Filing Litigation to Challenge FDA Delays in NDA or BLA Review

Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences ...
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, ...
Seeking Alpha

Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the ...
Morningstar

Orca Bio Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Orca-T® to Treat Hematological Malignancies

If approved, Orca-T would be the first allogeneic T-cell immunotherapy for the treatment of hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and ...
Fairfax Times

FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)

INOVIO filed its BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company has not submitted ...
Monthly Prescribing Reference

FDA Extends Review Period of Hunter Syndrome Gene Therapy

A new Prescription Drug User Fee Act target date of February 8, 2026 has been set for the application. The Food and Drug Administration (FDA) has extended the review for the Biologics License ...
Hosted on MSN

FDA sets 2026 decision clock for INOVIO’s rare disease therapy

PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) said the U.S. Food and Drug Administration has accepted its Biologics License Application for INO-3107, a potential non-surgical treatment for adults with ...
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 ...
Becker's Hospital Review

FDA floats changes to vaccine approval process: 5 notes

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
Targeted Oncology

For a Second Time, FDA Denies Approval of Tab-Cel in EBV+ PTLD

In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Seeking Alpha

Sangamo Therapeutics Announces FDA Acceptance of BLA Rolling Submission Request for ST-920 in Fabry Disease

RICHMOND, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Sangamo ...