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22:55 EST 21st November 2017 | BioPortfolio

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Oral Administration

Abiraterone Acetate - Zytiga

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...

Food Allergy

Simultaneous Administration of Different Vaccines

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Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)

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...

Priority review for Lilly’s breast cancer hopeful

The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for…

Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)

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,...

FDA approval for South Korean firm’s MAb drug substances plant

The US Food and Drug Administration has licensed the first monoclonal antibody (MAb) drug substance at…

MDMA’s Journey from Molly to Medicine

(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...

Valeant Is Selling Female Libido Pill Back To Former Owner, But Is Drug ‘Dead In The Water’?

The drug, Addyi, garnered lots of attention and controversy when it was approved by the Food and Drug Administration, but then it flopped.

FDA Reauthorization Act heads to Trump’s desk after Senate passage

David SalazarThe bill contains the reauthorizations of the Food and Drug Administration’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts. read more

Eli Lilly's Lasmitidan Significantly Reduces Pain in Patients with Migraine

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.

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The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin.

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...

Change in Surgical Practice for Women With Leiomyomas After the U.S. Food and Drug Administration Morcellator Safety Communication.

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.

Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation.

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.

Behind the Black Box: The Evidence for the U.S. Food and Drug Administration Warning about the Risk of General Anesthesia in Children Younger than 3 Years.

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...

Trends in Mode of Hysterectomy After the U.S. Food and Drug Administration Power Morcellation Advisory.

To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines.

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