Those with FGF19 overexpression often face significantly worse prognosis, and thus new treatment options are urgently needed. The Breakthrough Therapy Designation granted to irpagratinib will expedite ...

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for sonrotoclax, a ...

The company, which focuses on psychedelic-based medicine, had a busy few days on both the regulatory and financing fronts.

Shares of Spruce Biosciences (NASDAQ:SPRB) jumped 60% on Monday after the company announced that the U.S. Food and Drug ...

An investigational drug, bexicaserin has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation. The medicine has also been granted BTD by the U.S. Food and Drug ...

- Based on Type C meeting and new data, Dyne submitted revised ACHIEVE trial protocol to FDA elevating vHOT to primary endpoint for U.S. Accelerated Approval - - New positive clinical data from Phase ...

New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.

Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant’s efficacy and favorable safety profile Trial completion expected by Q4 2025 (including a ...

Cidara Therapeutics wins FDA Breakthrough Therapy tag for CD388 for the prevention of seasonal influenza. Stock rises.

Revolution Medicines, Inc. announced that the U.S. FDA has granted Breakthrough Therapy Designation to daraxonrasib, a multi-selective inhibitor targeting KRAS G12 mutations in patients with ...

SHANGHAI, May 26, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received ...