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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...
U.S. Food and Drug Administration tests found hepatitis A in scallops from the Philippines, which have been identified as the likely source of an outbreak of the virus in Hawaii.
// Undisclosed: U.S. Food and Drug Administration: Recruiting for three qualified and motivated individuals, with Ph.D. and/or M.D. degrees, for career-conditional PI positions … Silver Spring, ...
After months of deliberation, the U.S. Food and Drug Administration announced it is mandating stronger warnings and more studies for Bayer’s controversial Essure Permanent Birth Control device. ...
VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-spec...
The U.S. Food and Drug Administration's (FDA) approval yesterday of the second U.S. biosimilar, Inflectra™(infliximab-dyyb), is a positive step in the pursuit of affordable drug prices.
(CNN) – The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in t...
The Food and Drug Administration (FDA), in the US, has approved Celltrion’s Inflectra (infliximab-dyyb) – a biosimilar to infliximab – for multiple conditions, including rheumatoid arthritis and...
The Food and Drug Administration has taken steps to ensure the safety of the Essure method of permanent birth control. The agency has issued a new, mandatory clinical study to determine heightened r...
Zolpidem is a sedative-hypnotic widely prescribed in the United States. Recently, the US Food and Drug Administration (FDA) issued a drug safety communication regarding its dosing in women.
In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administrati...
To determine aspects of the design of pediatric registries that contribute to the success of registries conducted as a postmarketing study following approval of drugs or biological products by the US ...
Prompted by patients' changing perceptions of transvaginal mesh, this study examines how mesh has been reported in the news following the 2011 US Food and Drug Administration (FDA) updated notificatio...