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01:56 EDT 2nd May 2016 | 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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Sanofi Pasteur's dengue vaccine Dengvaxia gets approval in Philippines

Sanofi Pasteur has received marketing approval from the Philippines' Food and Drug Administration for Dengvaxia to prevent all four dengue types in individuals aged from nine to 45 years and living in...

FDA Mandates Essure Black Box Warning, More Safety Studies

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. ...

Sanofi Pasteur dengue vaccine approved for Philippines

A vaccine for the dengue virus developed by Sanofi Pasteur has been approved for use in the Philippines. The Philippine Food and Drug Administration has officially approved Dengvaxia to be ...

China Mandates Use Of Generic Names For All Medical Devices

The China Food and Drug Administration has finalized a new rule that will make it mandatory for all medtech companies to use only generic terms for naming medical devices being marketed in China.

Prime Therapeutics Statement On U.S. Food And Drug Administration's Approval Of Biosimilar Inflectra

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.

U.S. Food And Drug Administration Approves Humulin R U-500 KwikPen

INDIANAPOLIS, Jan. 21, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin R U-500 KwikPen (insulin human injection) 500 units/mL, a pre-fille...

Sanofi collaborates with Iran Food and Drug Administration

French pharmaceutical firm Sanofi has signed a Memorandum of Cooperation (MoC) with the Iran Food and Drug Administration, affiliated to the Ministry of Health and Medical Education of Iran, in order ...

FDA Mandates New Warnings, New Data for Essure Contraceptive Device

(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...

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Impact of a US Food and Drug Administration Drug Safety Communication on Zolpidem Dosing: An Observational Retrospective Cohort.

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.

Food and Drug Administration Drug Approval Process: A History and Overview.

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...

Use of data mining at the food and drug administration.

This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA).

Arrhythmia associated with buprenorphine and methadone reported to the Food and Drug Administration.

To assess the relative frequency of reporting of adverse events involving ventricular arrhythmia, cardiac arrest, QTc prolongation, or torsade de pointes to the US Food and Drug Administration (FDA) b...

Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success.

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 ...

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