The FDA's new Breakthrough ... been for cancer drugs. And in terms of oncology branding, it makes perfect sense. Breakthrough status is a far better branding strategy than orphan disease ...

Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment ...

Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter ...

Rigel Pharmaceuticals on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its proposed R289 treatment for myelodysplastic syndromes, a group of rare blood cancers ...

Receiving FDA Breakthrough Therapy and ... Track designation and EMA Committee for Orphan Medicinal Products (COMP) positive opinion on orphan drug designation received earlier this year.

The FDA has granted Cour Pharmaceuticals orphan drug designation for CNP-104, a biodegradable nanoparticle in development for ...

DOVER, Del. and EPALINGES, Switzerland, Dec. 10, 2024 /PRNewswire/ -- Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD ...

Taletrectinib, which is an oral, potent, central nervous system-active, selective agent, previously received orphan drug designation from the FDA and is currently the only ROS1 TKI in development that ...

--(BUSINESS WIRE)--AliveGen USA Inc. (AliveGen), a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ...

Beyond glioblastoma, paxalisib is being tested in other cancers, and the company plans to outline its strategic path forward ... from the FDA, including Orphan Drug and Fast Track Designations ...