Vical Garners Orphan Status for Experimental Antifungal January 12, 2016 VL-2397 is designed to fight invasive aspergillosis. Read More
Gem Snags Orphan Drug Designation for GPX-150 January 12, 2016 The candidate is in studies for soft tissue sarcoma. Read More
Vtesse Rakes in Breakthrough Therapy Designation for VTS-270 January 12, 2016 The cyclodextrin treatment is intended for patients with the rare genetic Niemann-Pick Type C1 Disease. Read More
Ionis Pharmaceuticals Nabs Orphan Drug Designation for Huntington’s Candidate January 11, 2016 IONIS-HTTRx would be the first treatment to combat the root cause of the fatal neurological disease. Read More
GBT Scoops Up Orphan Drug Status for Sickle Cell Candidate January 11, 2016 GBT440 could be the first disease-modifying treatment in the genetic blood condition that causes organ damage. Read More
FDA Awards Priority Review to Gilead for Hep C Combo Drug January 11, 2016 The drugmaker’s case for the NDA stems from four international Phase 3 trials. Read More
PhRMA, BIO Push Labeling Distinctions for Biosimilars January 8, 2016 Two major trade groups are pressing the FDA to draw sharp labeling distinctions between biosimilars and the products they mimic. Read More
Pluristem Scoops Up Orphan Drug Designation for PLX-PAD Cells January 8, 2016 The cells are designed for the treatment of severe preeclampsia. Read More
FDA Grants Dr. Reddy’s Tentative Approval for Generic Toviaz January 8, 2016 Toviaz is indicated for the treatment of overactive bladder symptoms. Read More
FDA Greenlights Changes for Merck’s Noxafil Antifungal Label January 8, 2016 The drug labels were revised to indicate that the two oral formulations cannot be substituted for each other. Read More
Regenxbio Scores Rare Pediatric Disease Designation for Gene Therapy January 7, 2016 RGX-111 uses an adeno-associated virus vector to deliver the human IDUA gene to the central nervous system. Read More
Unimed, Besins Sue Sandoz for Challenge to AndroGel Patents January 7, 2016 Two companies are suing generic drugmaker Sandoz for challenging their patents to the testosterone gel product AndroGel. Read More