Precigen, Inc. (NASDAQ:PGEN), a biotechnology company specializing in gene and cell therapies with a market capitalization of $398.3 million, is on the cusp of a significant transformation as it ...
Phase III Vivacity-MG3 trial shows that nipocalimab, an investigational FcRn blocker, significantly the improves symptoms of generalized myasthenia gravis with a manageable safety profile.
The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...
Intellia Therapeutics has dosed the first subject in the Phase III trial of NTLA-2002, to treat hereditary angioedema (HAE).
While most of its current revenue comes from the contract manufacturing business, Samsung Biologics aims to increase its exposure in the contract development organization business, which provides a ...
The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22 ...
The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.
The FDA accepts and grants priority review to Replimune's BLA for RP1 in combination with Opdivo for advanced melanoma. A decision is due on Jul.
The company expects to submit a biologics license application for NTLA-2002 in 2026 and potentially launch it in the US in 2027.
Elicio Therapeutics (ELTX) announced that it has received supportive feedback in an End of Phase 1 Type B meeting with the U.S. Food and Drug ...
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the ...
The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.