Merck stops early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension due to positive stud...
Neurogene says a patient dosed in an ongoing Phase 1/2 gene therapy clinical trial for Rett syndrome has died.
Endo recalls (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength.
FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental health issues, Reut...
ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devices.
FDA grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metastatic HER2-positive bi...
FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.
FDA clears a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Command Center.
