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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...
WALTHAM, Mass.--(BUSINESS WIRE)--Oct. 25, 2017-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA) today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administ...
The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for…
ARDSLEY, N.Y.--(BUSINESS WIRE) June 29, 2017 -- Acorda Therapeutics, Inc. (NASDAQ: ACOR) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Inbrija (CVT-301,...
The US Food and Drug Administration has licensed the first monoclonal antibody (MAb) drug substance at…
(Scientific American) – The speed and effectiveness of the psychedelic experience Casey describes has caught the attention of the Food and Drug Administration, despite the Drug Enforcement Admin...
The drug, Addyi, garnered lots of attention and controversy when it was approved by the Food and Drug Administration, but then it flopped.
David SalazarThe bill contains the reauthorizations of the Food and Drug Administration’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts. read more
NewsLilly plans to submit a New Drug Application for lasmiditan to the U.S. Food and Drug Administration (FDA) in the second half of 2018.
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 evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas.
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.
On December 14, 2016, the U.S. Food and Drug Administration issued a Drug Safety Communication warning "that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or proced...
To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines.