FDA does little about it, study finds.

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. 

Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.

Lucemyra is the first non-opioid drug to be approved in the U.S. specifically for this purpose.

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.

The legislation removes restrictions for seriously ill patients to access experimental treatments that have not received FDA approval.

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.

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

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