The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

Ultragenyx Pharmaceuticals RARE announced that the FDA has issued a Complete Response Letter (CRL) for its biologics license ...

Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...

Shares of Capricor Therapeutics CAPR tanked 33% on Friday after it announced that the FDA issued a complete response letter ( ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease.

These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.

Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure Provided by GlobeNewswire Jun 30, 2025, 5:36:48 PM ...

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States ...

Mesoblast’s RYONCIL ® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal ...

(3) Furthermore, it states that “FDA Approvals for 2004 and after include Biologic License Applications (BLAs) for therapeutic biologic products.” (3) The present Viewpoint was prompted by this ...