Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

When approved, ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust ...

Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has accepted ...

Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD

BLA submission based on positive results from Phase 3 INDIGO trial -WALTHAM, Mass., May 28, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc.
Nasdaq

Biologics License Application for Subcutaneous Formulation of "LEQEMBI(R)" (lecanemab) for the Treatment of Early Alzheimer's Disease Accepted in China

TOKYO and CAMBRIDGE, Mass., Jan 6, 2026 - (JCN Newswire) - - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate ...
Seeking Alpha

AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) - an Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer with ...

- BLA based on data from the global Phase 1/2 CADENZA trial NORTH CHICAGO, Ill., Sept. 30, 2025 /PRNewswire/ -- AbbVie (ABBV) today announced submission of a new Biologics License Application (BLA) to ...

Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)

Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen resulted in a robust and ...
Healio

FDA accepts new supplemental biologics license application for review for Winrevair

Please provide your email address to receive an email when new articles are posted on . Phase 3 ZENITH trial data assessing Winrevair in adults with WHO functional class III or IV PAH support the new ...
Healio

FDA accepts biologics license application for Merck’s RSV shot

Please provide your email address to receive an email when new articles are posted on . Clesrovimab is a monoclonal antibody that protects against RSV subtypes A and B. The FDA set a PDUFA date for ...
Nasdaq

Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva ...
Seeking Alpha

Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug ...
Business Wire

Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with ...

Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE ® FL-1 trial Full results from the trial will be ...
JD Supra

Biological Products Regulation Part 5: Preparing for the FDA’s Pre-License Inspection

In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...