The company and its partner halted two clinical trials for futility early this year, but now say they’ll seek approval for aducanumab.

Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.

The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.

The FDA has given the green light to the first major new classes of antidepressant therapies in decades, opening up new avenues for therapeutic development.

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.