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.

A contaminated ham put bacteriologist Émile Pierre-Marie van Ermengem on the path to discovering the microbe that produces botulinum toxin.

With multiple microbiota therapeutics in the pipeline for recurrent Clostridium difficile infection, clinicians foresee a shift in treatment options for the condition.

Now more than ever before, recruiting patients for a research study doesn’t have to mean getting them to leave their homes.

The decision, which concerns the removal of a sugar molecule on the surface of cells in a line of domestic pigs, marks the first time an approval has been granted for both purposes simultaneously.

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

Although scientists debate the ethics of deliberately infecting volunteers with SARS-CoV-2, plenty of consenting participants have been exposed to all sorts of pathogens in prior trials.

Researchers say the popularity of convalescent plasma makes it more difficult to gather high-quality data on its efficacy.

Screens of hundreds of drug excipients reveal that some can interact with biological targets, contradicting their FDA categorization as inert.

The physician-researcher laid the groundwork for genetic cloning and led the US Food and Drug Administration as the country faced the AIDS crisis in the 1980s.

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.

Two coauthors of a new study discuss their findings about nearly 170 facilities in the southwestern US selling unproven therapies—and what should be done about them.

FDA researchers report that multiple active ingredients wind up in users’ bloodstream and recommend toxicology testing to investigate the clinical significance of the findings.

The fast-growing fish can now be raised and sold in the US, although it’s likely to be some time before the product hits the market.

Conceived as a way to resolve differences between government regulators and academics over the chemical’s effects, the CLARITY-BPA collaboration instead highlights divisions.

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.