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On April 28, 2011, the US Food and Drug Administration (FDA) approved Zytiga (abiraterone acetate), for use in combination with prednisone for the second-line treatment of castration-resistant prost...
The country's Food and Drug Administration called on the French pharma to pull radio and television ads for its Dengue fever vaccine, Dengvaxia.
This Viewpoint summarizes recommendations made in a 2017 Blueprint for Transparency at the US Food and Drug Administration developed to encourage increased public access to FDA analyses and regulatory...
The US Food and Drug Administration has approved plecanatide (Trulance; Synergy Pharmaceuticals) as another option for the treatment of chronic idiopathic constipation (CIC) in adults.
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is…
President Donald J. Trump's pick to lead the Food & Drug Administration, Scott Gottlieb, wants to get new drugs, including low-cost generics, on the market faster. A physician with leadership ...
The Philippines came under global pressure Monday over its deadly drug war, facing calls for action following an alleged wave of extrajudicial killings. Diplomats from all continents raised concern o...
January 25, 2017 – Dublin, Ireland – Today, the U.S. Food and Drug Administration (FDA) approved Narcan Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid ov...
Monday, April 24th 2017 at 5:06am UTC INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (...
To summarize the US Food and Drug Administration's (FDA's) review of the safety and effectiveness for pimavanserin, an atypical antipsychotic, for the treatment of hallucinations and delusions associa...
To examine the association between the 2014 U.S. Food and Drug Administration (FDA) safety communication on power morcellation and surgical approach and morbidity after myomectomy.
To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines.
The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Fe...
To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA).