Policy & Regulation
Targovax wins patent for Mutant-RAS neoantigen platform lead products in Europe
17 January 2019 - Immuno-oncology company Targovax ASA (OSE:TRVX) revealed on Wednesday the receipt of the European patent that will protect its mutant-RAS specific neoantigen peptides, mutant RAS spe...
Therachon awarded US FDA's orphan drug designation for apraglutide for the treatment of short bowel syndrome
17 January 2019 - Biotechnology company Therachon AG said on Wednesday that it has passed the US Food and Drug Administration's (FDA) orphan drug designation for apraglutide for the treatment of ...
Bridge wins US FDA's orphan drug designation for BBT-877 in IPF, with first-in-human clinical study set to begin next month
17 January 2019 - Biotech company Bridge Biotherapeutics Inc revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) orphan drug designation (ODD) to promote the developm...
Acurx Pharmaceuticals LLC awarded the US FDA's fast track designation for 362E for Clostridium difficile Infection
17 January 2019 - Biopharmaceutical company Acurx Pharmaceuticals LLC revealed on Wednesday the receipt of the US Food and Drug Administration's Fast Track designation to facilitate the developme...
Amgen & UCB wins the US FDA BRUDAC's recommendation for approval of EVENITY for treating osteoporosis in postmenopausal women
17 January 2019 - Human therapeutics company Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels:UCB) on Wednesday jointly announced the US Food and Drug Administration (FDA) Bone, Reproductive and Urologi...
Acurx Pharmaceuticals' C. difficile drug receives Fast Track designation from UD FDA
17 January 2019 - Acurx Pharmaceuticals LLC, a clinical stage, privately-held biopharmaceutical company focused on developing new antibiotics for difficult-to-treat bacterial infections, announced yes...