The FDA granted Breakthrough Therapy status to Incyte's experimental treatment for a rare blood cancer. Incyte stock is basing near five-year highs.

Rusfertide, a hepcidin-mimetic peptide, reduces excess red blood cell production in polycythemia vera, addressing complications like blood clots and fatigue. The FDA granted rusfertide breakthrough ...

Breakthrough designation for rusfertide was supported by positive 32-week data from the Phase 3 VERIFY study, which was presented as a late breaking abstract highlighting its practice-changing ...

The Breakthrough Therapy Designation was granted based on the positive topline results from the Essential3 Phase 3 program in essential ...

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, ...

DYNE-251 received FDA breakthrough therapy designation for DMD, showing promising clinical evidence of improvement over existing therapies. The DELIVER trial demonstrated sustained functional ...

Sonrotoclax, a BCL2 inhibitor, received FDA breakthrough therapy designation for relapsed or refractory mantle cell lymphoma, indicating its potential to transform patient outcomes. The drug is ...

LEXINGTON, Mass., Oct. 23, 2025 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) ...

Please provide your email address to receive an email when new articles are posted on . Cidara announced Thursday that it received a breakthrough therapy designation from the FDA for an ...