FDA

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.

In his book’s Introduction, physician-scientist Paul A. Offit reviews the unusual constellation of circumstances around the development of COVID-19 vaccines.

President Biden’s planned rollout of additional COVID-19 vaccine doses is set to begin next week, but questions remain about who should get them.

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

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.

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 lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.

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

Johnson & Johnson’s one-shot immunization could reach people’s arms as early as March 2.

As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.