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image: Second-Ever ALS Drug Approved

Second-Ever ALS Drug Approved

By | May 8, 2017

Amyotrophic lateral sclerosis patients in the U.S. now have an option besides riluzole, which was approved by the FDA more than two decades ago and only extends life by two or three months.

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image: Drugs OKed Faster in U.S. Than in Europe

Drugs OKed Faster in U.S. Than in Europe

By | April 10, 2017

In recent years, the US Food and Drug Administration has approved more drugs and in less time than the European Medicines Agency.

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image: Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy

Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy

By | February 1, 2017

What can be done to lower development costs and drug prices?

4 Comments

image: Biomedical Research Bill Approved in House

Biomedical Research Bill Approved in House

By | December 1, 2016

The 21st Century Cures Act could provide funds to federal research agencies for the decade and accelerate the drug approval process.

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image: Q&A: From FDA to Industry

Q&A: From FDA to Industry

By | September 27, 2016

Among a subset of US Food and Drug Administration regulators who leave the agency, more than half go to work for pharmaceutical companies, researchers report.

1 Comment

image: First Dengue Vax Approved

First Dengue Vax Approved

By | December 11, 2015

Mexico’s health ministry has OKed the vaccine for people between nine and 45 years old.

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image: Drug Produced in GM Chicken Approved

Drug Produced in GM Chicken Approved

By | December 10, 2015

The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.

1 Comment

image: Doctor Who Blocked Thalidomide Dies

Doctor Who Blocked Thalidomide Dies

By | August 11, 2015

Frances Oldham Kelsey, a physician who halted use of a drug that caused birth defects in babies, has passed away at age 101.

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image: FDA OKs First Biosimilar

FDA OKs First Biosimilar

By | March 6, 2015

The US Food and Drug Administration approves Sandoz’s Zarxio, a biosimilar to Amgen’s filgrastim, which is mainly prescribed for cancer patients.

2 Comments

image: FDA Head Leaving Post

FDA Head Leaving Post

By | February 6, 2015

US Food and Drug Administration commissioner Margaret Hamburg is stepping down after six years on the job.

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