drug approval

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

No deaths had previously been associated with the muscle-wasting treatment Zolgensma.

A lack of comprehension among some researchers about how to use ClinicalTrials.gov may be hindering public access to trial information and holding up drug study results, an investigation by The Scientist finds.

Moderna and Pfizer-BioNTech shots could be given to the youngest kids as early as June 21.

The country’s provisional go-ahead could increase pressure already being exerted on the US Food and Drug Administration to approve the therapy.

A narrow Senate vote ends a 13-month period during which the agency has lacked a permanent commissioner.

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.