FDA grants breakthrough therapy designation to Vertex VX-548 for some acute and neuropathic pain indications.
FDA warns Dr. Daniel Goodman about objectionable conditions in a clinical trial at his San Francisco, CA-based Goodman Eye Center.
FDA publishes a guidance to help drug sponsors who are planning to conduct clinical studies in neonatal populations.
FDA issues a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits...
Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the company requested the...
Federal Register notice: FDA sends to OMB a new information collection entitled Pharmaceutical Voluntary Consensus Standard Recognition.
Reuters reports that the Department of Justice has opened a criminal investigation into Cassava Sciences over allegations it manipulated results in a ...
FDA approves Bavarian Nordics fill and finish facility in Denmark to manufacture its Jynneos smallpox/monkeypox vaccine.