Moderna says norovirus vaccine trial on FDA clinical hold
Moderna (MRNA) said that the two-season Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against ...
Healio1d
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
Senators call on FDA to act against misleading weight-loss drug commercials
Commercials run by the telehealth company Hims & Hers have been placed under the microscope as lawmakers are calling out the advertisement of prescriptions for injectable weight-loss drugs without ...
STAT2d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
JD Supra2d
DOJ and 18 States Reach False Claims Act Settlement with QOL
The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its ...