FDA

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.

The immunizations are designed to target the latest Omicron subvariants, and are only authorized for people who have already received their primary vaccinations.

The newly authorized intradermal vaccination only requires one-fifth of the usual vaccine dose. This will help stretch out the limited vaccine supply, experts say, but only if healthcare personnel receive sufficient training.

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

Studies show that a fourth mRNA vaccine dose offers the elderly and other high-risk groups strong protection against hospitalization and death from COVID-19, but experts say benefits for other populations may be more limited.

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.

Agency members express hope that the availability of a traditional, protein-based vaccine might convince holdouts to get vaccinated.

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.

US adults are now only eligible for the vaccine under certain circumstances.

The retracted studies were coauthored by a scientist who worked on an Alzheimer’s therapy in development by Cassava Sciences, a company reportedly under investigation for providing falsified data to the FDA.

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

The Smith-Kettlewell Eye Research Institute scientist developed Botox for medicinal use.

Given within three days of symptom onset, the pill combination was nearly 90 percent effective at preventing high-risk patients from developing severe illness in a clinical study.

As Omicron induces a sense of deja vu at the close of the year, we look back at a few key ways in which our understanding has moved forward.

Current evidence suggests the treatment does not improve survival or reduce the need for ventilation in COVID-19 patients, the World Health Organization says.

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.

With the final hurdle cleared, the COVID-19 vaccine could be administered to US children ages 5 through 11 as early as today.

Merck reports that its antiviral molnupiravir was effective against early stages of COVID-19 in high-risk patients in a Phase 3 clinical trial.