clinical data

Researchers overseeing the clinical trial for the first FDA-approved oral contraceptive claimed the drug gave the Puerto Rican participants power over their family planning. Critics claimed the women were exploited.

Researchers caution that it’s too soon to recommend supplements based on the results of a new study.

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.

A device designed by researchers at MIT can image the wearer’s internal organs for up to 48 hours, even as that person exercises, so long as they stay wired up to imaging equipment.

The biotech company Verve Therapeutics launched the study with the aim of using base editing to treat a genetic condition that causes high cholesterol and increases a person's risk of developing cardiovascular disease.

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

The US FDA’s decision not to grant an emergency use authorization for the antidepressant as a COVID-19 treatment highlights a lack of consensus among researchers about how to interpret clinical data on the drug.

Researchers are revealing the complexity of the microbial community living on the body—and paving the way for new bacteria-targeting treatments for acne and other dermatological conditions.

A first-of-its-kind gene therapy dramatically reduced misfolded protein levels in some clinical trial participants for up to six months and reduced levels in all participants for up to a year.

A new regulation and registry covering investigational medicinal products mandates reporting and supports multinational trials.

Health Canada has given the single COVID-19 shot the official greenlight for use in people 18 and older.

The cardiologist was briefly the FDA Commissioner in the Obama Administration, and now has a second chance to act on plans he tried to implement during his first tenure.

Authors of a newly published study on the use of an antidepressant for COVID-19 claim the drug greatly reduces hospitalizations and mortality. But some experts question whether that’s really what the data show.

The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.

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

Some children who experience the severe inflammatory condition after COVID-19 may continue to experience milder problems such as muscle weakness or anxiety even after that period, according to a small observational study in the UK.

Researchers integrated information from 45 protein, metabolite, and immune data points to identify a window two to four weeks before a pregnant person will go into labor.

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