IntelGenx (TSXV:IGX; OTCQX:IGXT) resubmitted its 505(b)(2) new drug application for RIZAPORT VersaFilM for the treatment of acute migraines to the FDA. “Over the past several months, we have been working diligently to...
Several large laboratories have successfully completed validation studies to test Precipio’s (NASDAQ:PRPO) IV-Cell cytogenetics media product, as well as its HemeScreen assay, and are proceeding towards placing orders...
Cortexyme (NASDAQ:CRTX) began screening patients in Europe for its international Phase 2/3 trial, called GAIN, to evaluate COR388 in patients with mild-to-moderate Alzheimer’s disease (AD). The company has been...
Marinus Pharmaceuticals (NASDAQ:MRNS) reported positive topline results from its Phase 2 trial of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE). Status epilepticus is a prolonged...
Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) recently met with the FDA to discuss its premarket approval regulatory pathway for marketing authorization of its i/Blue Imaging System. Based...
UroGen Pharma (NASDAQ:URGN) reported results from its Phase 3 and Phase 2b trials of its mitomycin gel in patients with low-grade upper tract urothelial cancer (UTUC) and intermediate risk low-grade non-muscle invasive...
Achillion Pharmaceuticals’ (NASDAQ:ACHN) danicopan received FDA breakthrough therapy designation for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). In PNH, the complement system destroys red blood cells in...
The Safety Review Committees overseeing Salarius Pharmaceuticals’ (NASDAQ:SLRX) Phase 1/2 clinical study of Seclidemstat in Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors...
Mateon Therapeutics’ (NASDAQ:MATN) OT-101 received FDA pediatric disease designation for the treatment of diffuse intrinsic pontine glioma (DIPG). DIPG is a rare pediatric brainstem tumor that has a very low survival...
Ovid Therapeutics (NASDAQ:OVID) reported positive initial data from its Phase 2 study of soticlestat, a cholesterol 24-hydroxylase inhibitor, in patients with rare developmental and epileptic encephalopathies (DEE). ...