FDA tells Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline)...
Pfizer and BioNTech begin a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate.
FDA publishes a guidance on using patient-reported outcome instruments in medical device evaluation.
FDA warns Chino, CA-based Health Plus about CGMP violations in its manufacturing of finished pharmaceuticals.
Four stakeholders suggest changes to a draft FDA guidance on using electronic health records and claims data to support drug and biologic regulatory d...
FDA announces a 4/5-6 virtual public workshop entitled Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treat...
The CDER Office of Prescription Drug Promotion accepts Lillys explanation of issues raised about Emgality TV ads and closes an untitled letter on the ...
FDA clears a Biotricity 510(k) for its Biotres Cardiac Monitoring Device, a three-lead holter device for electrocardiogram and arrhythmia monitoring.