US FDA approves Syndax's blood cancer drug
The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and ...
FDA grants orphan drug designation to potential treatment of STXBP1 developmental and epileptic encephalopathy
Research that was carried out by Baylor College of Medicine and Texas Children's Hospital doctors has led to the U.S. Food ...
FDA approves Cobenfy for adults with schizophrenia
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first ...
FiercePharma2d
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...
MassDevice3d
FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Business Insider4d
Actuate Announces FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma
If, in the future, a New Drug Application (NDA) for elraglusib for the treatment of Ewing sarcoma is approved by the FDA, Actuate will be eligible to receive a Priority Review Voucher (PRV) that could ...