Sotatercept-csrk was first approved in 2024 to treat pulmonary arterial hypertension (PAH) in adults based on results seen in the phase 3 STELLAR trial.

Capricor Therapeutics (CAPR) shares fell Friday after the company announced it received a complete response letter from the FDA for its Biologics License Application for Deramiocel.

Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced several strategic leadership appointments within its Drug Product team. These ...

Duality Biotherapeutics' ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage ...

IVEN Shines at CPHI China 2025 IVEN logo IVEN factory SHANGHAI, SHANGHAI, CHINA, July 5, 2025 /EINPresswire / -- As the global p ...

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England Journal of Medicine on May 20 requiring a stronger evidence base for boosters ...

What's driving this $370 million transformation? The global residual DNA testing market, valued at US$0.27 billion in 2024, ...

The Riverview site provides comprehensive drug substance development and manufacturing services, including spec ...

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.