biologics

Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy

Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgANORIGIN Phase 3 trial met its primary endpoint at the…

4 weeks ago

BlueWillow Biologics Intranasal Bird Flu Vaccine Shows Signs of Broad Immune Response in Phase I Clinical Trial Published in Nature Communications

ANN ARBOR, Mich., Nov. 06, 2025 (GLOBE NEWSWIRE) -- BlueWillow Biologics, Inc., a clinical-stage biotech company pioneering the future of…

4 weeks ago

Alvotech Provides Update on the Status ofU.S. Biologics License Application for AVT05

REYKJAVIK, Iceland, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and…

1 month ago

Aurora Spine Launches New Biologics Portfolio

New Aurora Biologics Division Establishes Aurora Spine as a Vertically Integrated Source for Spinal Implants and Biologics October 27, 2025…

1 month ago

NeXtGen Biologics Announces Issuance Of A Third New Patent Covering Axolotl-Derived Technology

GAINESVILLE, Fla., Oct. 07, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announces the issuance of a third U.S. patent, US12311079, on…

2 months ago

Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI IQLIK(lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimers Disease Under Fast Track Status

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from…

3 months ago

WuXi Biologics Launches HEK 293 Stable Cell Line Platform WuXia293 Stable for Development and Manufacturing of Difficult-to-Express Molecules

WuXia293Stable platform demonstrates high titer, human glycosylation and improved product quality by eliminating or significantly alleviating truncation in difficult-to-express molecules.WuXia293Stable platform maintains…

4 months ago