Aldeyra Therapeutics says the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis met...
A Florida federal judge stays the states Administrative Procedure Act claims against FDA over the states drug import plan until 11/1, noting that FDA ...
Pfizer says select presentations of its Bicillin L-A and Bicillin C-R prefilled syringes are expected to be depleted later this year.
FDA clears a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System.
Federal Register notice: FDA makes available a final guidance entitled Content of Premarket Submissions for Device Software Functions.
The CDER Biomarker Qualification Program says it supports four pancreatic injury microRNA biomarkers identified and evaluated by the C-Path Predictive...
Two Sheppard Mullin attorneys describe FDAs latest effort to improve written patient-facing drug safety and efficacy information.
2seventy bio says its Seattle Childrens partner has paused a Phase 1 pediatric acute myeloid leukemia trial following a patient fatality.
