FDA approves an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for ...
FDA Review posts product approval summaries for the week ending 11/5/2021.
Federal Register notice: FDA sends to OMB an information collection revision for a guidance entitled Postmarketing Adverse Experience Reporting and Re...
Federal Register notice: FDA amends the animal drug regulations to reflect recent application-related actions for new animal drug applications and abb...
FDA issues a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after finding GMP problems during an inspection in July.
Promising new data on its investigational Covid-19 oral antiviral agent Paxlovid PF prompts Pfizer to plan its early submission to the ongoing rolling...
FDA grants ReWalk Robotics a breakthrough device designation for its ReBoot, an exo-suit intended to assist ambulatory functions in individuals with r...