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

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

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

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

CERo Therapeutics Holdings Inc (NASDAQ:CERO) shares are trading higher Tuesday after the company received U.S. Food and Drug ...

Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing ...

FDA recommends inclusion of patients as young as 6 months - younger than Moleculin had proposed - to be allowed in the ...

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

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 ...

Investing.com -- CERo Therapeutics Holdings Inc (NASDAQ: CERO) stock surged 191.6% after the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the company’s lead drug ...

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 Commissioner's National Priority Voucher (CNPV) programme will be available to companies aligned with pressing matters ...