The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).
The Food and Drug Administration (FDA) has granted Fast Track designation to SB-525 (Sangamo Therapeutics) for the treatment of hemophilia A.
Ionis announced positive results from the Phase 3 study of inotersen (IONIS-TTRRx) for the treatment of familial amyloid polyneuropathy (FAP), now referred to as hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).
The FDA has granted Fast Track designation to trigriluzole (BHV-4157; Biohaven) for the potential treatment of Spinocerebellar Ataxia (SCA), a rare and debilitating neurodegenerative disorder.
Lilly announced encouraging results from three Phase 3 studies of galcanezumab, EVOLVE-1, EVOLVE-2 and REGAIN, evaluating its efficacy and safety for the prevention of episodic and chronic migraine.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ribaxamase (SYN-004; Synthetic Biologics) for the prevention of Clostridium difficile infection (CDI).
A second Phase 3 trial for vonapanitase in hemodialysis patients, PATENCY-2, is currently ongoing and is expected to complete enrollment in the first quarter of 2018.
The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of TX-004HR (TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.