By the end of this month, two pharmaceutical firms are set to receive a decision on their drug approval applications from the U.S. Food and Drug ...

Please provide your email address to receive an email when new articles are posted on . Dupixent previously received priority review and orphan drug designation from the FDA for bullous pemphigoid.

(RTTNews) - Mesoblast (MESO, MSB.AX) announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration for Ryoncil (remestemcel-L) for treatment of ...

Crofelemer previously granted orphan-drug designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome and microvillus inclusion disease SAN FRANCISCO, CA / ACCESSWIRE ...

J & D Pharmaceuticals LLC announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's investigational therapy for the treatment of Hepatocellular ...

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...

Cintredekin besudotox targets IL-13 alpha-2 receptor in glioblastoma, aiming to spare healthy brain tissue while destroying cancer cells. Orphan drug designation offers benefits like lower fees and ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...