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.
Intera Oncology recalls its Intera 3000 Hepatic Artery Infusion Pump due to complaints the device was delivering medications faster than expected.
