In recent days, Gossamer Bio announced promising advancements for its lead candidate seralutinib, including new FDA designations and positive clinical progress targeting pulmonary arterial ...

Regulatory milestone adds to its existing Orphan Drug Designation, creating additional regulatory and financial advantages for the Company’s lead ...

NeuroNOS, a biopharmaceutical company focused on developing treatments for neurological disorders and neuro-oncology, and a subsidiary of Beyond Air (NASDAQ: XAIR), today announced that the U.S. Food ...

The designation specifically states that "GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu ...

D3S-001 received FDA breakthrough therapy and orphan drug designations for KRAS G12C-mutated NSCLC and CRC, expediting its development for serious and rare conditions. KRAS G12C mutations are ...

SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare ...

Sanofi SNY announced that the FDA granted fast track designation to its investigational gene therapy, SAR402663, for the ...

Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) today welcomed the U.S. Food and Drug Administration’s (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting ...