Senate Republicans released their version of the Trump administration’s “One Big Beautiful Bill Act” on Monday with a few ...

Shares of Cero Therapeutics Holdings drew increased retail investor chatter on Tuesday after the company said that the FDA ...

The biopharma industry has hit a setback in its ambition to leverage President Donald Trump’s “big, beautiful bill” to amend ...

A controversial proposal to change the Inflation Reduction Act’s pricing framework for rare disease drugs has been dropped ...

Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), ...

Circle Pharma receives US FDA orphan drug designation for its CID-078 to treat small cell lung cancer: South San Francisco, California Wednesday, June 18, 2025, 18:00 Hrs [IST] So ...

U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s ...

Capricor Therapeutics (NASDAQ:CAPR) received the Orphan Drug designation from the U.S. FDA for its lead cell therapy candidate, Deramiocel, to treat becker muscular dystrophy. With its orphan drug ...

CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to ...

Capricor Therapeutics has received an orphan drug designation for its drug aimed at potentially treating Becker Muscular Dystrophy. The biotechnology company said Tuesday that the Food and Drug ...

The designation qualifies CERo and CER-1236 for certain incentives, such as FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval ...