FDA clears a BrainsWay 510(k) for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and depression.
The state of Florida files a lawsuit against FDA for failing to timely respond to a state-sought Freedom of Information Act request seeking informatio...
Federal Register notice: FDA posts two draft guidances entitled Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development....
Federal Register notice: FDA issues bluebird bio a priority review voucher for obtaining approval of Zynteglo (betibeglogene autotemcel), indicated fo...
After reporting Phase 2 data, Bristol Myers Squibb and Janssen Pharmaceuticals say they are planning to begin a Phase 3 trial of their investigational...
FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a plastic contaminate...
Erytech Pharma says it is no longer planning to submit a BLA for Graspa in hypersensitive acute lymphoblastic leukemia following FDA feedback that req...
New Phase 3 data on AstraZeneca's Farxiga (dapagliflozin) demonstrate a mortality benefit compared to placebo in patients with heart failure.
