drug approval

The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.

The US Food and Drug Administration has called for a federal investigation of its own regulatory review process after widespread criticism of its decision on Aduhelm.

The recent move of the European Medicines Agency from London to Amsterdam is a reflection of the city’s vibrant life sciences and health sector and supporting industries.

Two new medications for treating a rare and deadly neuromuscular disease have high prices and questionable efficacies, say scientists.

The antiviral disables RNA replication machinery in MERS and SARS viruses. Can it beat back SARS-CoV-2?

Scientists speak up about landmark drug approvals, political and environmental activism, and the redefinition of death.

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.

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.