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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.

1 Comment

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.

0 Comments

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.

0 Comments

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.

0 Comments

image: Lazarus Drugs

Lazarus Drugs

By | February 1, 2015

While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.  

1 Comment

image: FDA Approves Another New Antibiotic

FDA Approves Another New Antibiotic

By | June 24, 2014

Second new drug to treat methicillin-resistant Staphylococcus aureus approved under US Food and Drug Administration incentive program. 

1 Comment

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