Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions during January, February, and March.
FDA approves an Adamis Pharmaceuticals NDA for Zimhi (naloxone HCl injection, 5 mg/0.5 mL) for treating opioid overdose.
Melinta Therapeutics says it did not receive a Nexus Pharmaceuticals Paragraph 4 certification for a generic form of Melintas Minocin in a timely mann...
FDA clears an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation System head, neck, and the front o...
FDA approves an Oyster Point Pharma NDA for Tyrvaya (varenicline solution) nasal spray 0.03 mg for treating signs and symptoms of dry eye disease.
FDA warns two Hennepin County Medical Center researchers they failed to submit INDs for their clinical investigations.
Sen. Richard Blumenthal (D-CT) tells a Bloomberg News reporter that he will likely oppose Duke University School of Medicine professor Robert Califfs ...
FDA warns Marcus Research Laboratory about CGMP deviations in its production of active pharmaceutical ingredients.