WY Biotech is now obligated to pay a $7 million upfront license fee to HCW Biologics by Sept. 30, according to a filing with the Securities and Exchange Commission. HCW Biologics previously said it ...

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

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and ...

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 ...

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

Denali Therapeutics, Inc. DNLI announced that the FDA has accepted for review its biologics license application (BLA) for ...

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.

Home News GlobeNewswire Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure ...

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 and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart FailureNEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in ...