Questions Raised About “Breakthrough” Therapies’ Clinical Support
Catherine Offord | Jul 17, 2018
Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.
Two CAR T-Cell Therapies Greenlighted in Europe
Two CAR T-Cell Therapies Greenlighted in Europe
Cancer treatments from Novartis and Gilead earn approval from EU regulators, but a first pass by the UK’s state-funded health service finds CAR T is too expensive.
Cancer treatments from Novartis and Gilead earn approval from EU regulators, but a first pass by the UK’s state-funded health service finds CAR T is too expensive.
FDA Approves Drug to Ease Symptoms of Opioid Withdrawal
Catherine Offord | May 17, 2018
Lucemyra is the first non-opioid drug to be approved in the U.S. specifically for this purpose.
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Jef Akst | Oct 12, 2017
Spark Therapeutics’s Luxturna would be the first approved therapy in the U.S. that replaces or repairs a defective gene inherited from one’s parents.
Right-to-Try Bill Passes the Senate
Catherine Offord | Aug 4, 2017
The legislation removes restrictions for seriously ill patients to access experimental treatments that have not received FDA approval.
Second-Ever ALS Drug Approved
Jef Akst | 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.
Drugs OKed Faster in U.S. Than in Europe
Kerry Grens | Apr 10, 2017
In recent years, the US Food and Drug Administration has approved more drugs and in less time than the European Medicines Agency.
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.