The US Food and Drug Administration green lights a therapy for an extreme form of multidrug resistant TB.

The agency is now evaluating the implications of the corrupted data behind Zolgensma and whether to “take action” against the pharmaceutical company.

The nasal spray to ease intractable depression appears on the US market after decades without novel antidepressant treatments.

A small pilot study suggests the approach can identify effective treatments already approved for other cancers.

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.