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Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
John D. Loike and Jennifer Miller | Feb 1, 2017
What can be done to lower development costs and drug prices?
Biomedical Research Bill Approved in House
Ben Andrew Henry | Dec 1, 2016
The 21st Century Cures Act could provide funds to federal research agencies for the decade and accelerate the drug approval process.
Q&A: From FDA to Industry
Kerry Grens | Sep 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.
First Dengue Vax Approved
Kerry Grens | Dec 11, 2015
Mexico’s health ministry has OKed the vaccine for people between nine and 45 years old.
Drug Produced in GM Chicken Approved
Jef Akst | Dec 10, 2015
The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.
Doctor Who Blocked Thalidomide Dies
Kerry Grens | Aug 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.
FDA OKs First Biosimilar
Tracy Vence | Mar 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.
FDA Head Leaving Post
Kerry Grens | Feb 6, 2015
US Food and Drug Administration commissioner Margaret Hamburg is stepping down after six years on the job.
Kate Yandell | Feb 1, 2015
While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.
FDA Approves Another New Antibiotic
Jyoti Madhusoodanan | Jun 24, 2014
Second new drug to treat methicillin-resistant
approved under US Food and Drug Administration incentive program.