The U.S. Food and Drug Administration (FDA) has announced the approval of Qfitlia (fitusiran), a treatment designed to ...

In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.

The FDA has granted orphan drug designation to PEP-010 for pancreatic cancer, advancing its development as a potential novel ...

Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal ...

Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström Macroglobulinemia First-in-class Bruton’s tyrosine kinase (BTK) degrader NX-5948 ...

ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA ...

LUND, SE / ACCESS Newswire / March 20, 2025 /Alligator Bioscience (Nasdaq Stockholm:ATORX) today announces that the U.S. Food ...

Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma ...

Evaluate, the leading provider of market insights for the pharmaceutical industry, today released its 2025 Orphan Drug Report highlighting forecasts for the orphan drug market out to 2030. The 2025 ...

The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line ...

Nurix on Monday said the FDA granted orphan-drug designation to bexobrutideg, also known as NX-5948, for the treatment of Waldenstrom macroglobulinemia, a slow growing type of non-Hodgkin's lymphoma ...