FDA

Biotech company Moderna has revealed more data from its Phase 3 COVID-19 vaccine trial, reporting the vaccine is 94.1 percent effective at preventing COVID-19. An FDA review evaluating Emergency Use Authorization is now scheduled for December 17.

Pfizer and BioNTech have announced their large Phase 3 COVID-19 vaccine trial is complete. The trial has reportedly met all its primary endpoints and the vaccine is claimed to be 95 percent effective.

A phase 2 clinical trial of a cholesterol-reducing drug called evinacumab has reported promising results. In patients with extremely high cholesterol, the drug was able to reduce levels by about half, compared to a placebo.

The FDA has approved a platform called NightWare, designed to help improve sleep in post-traumatic stress disorder patients suffering from recurrent nightmares. The system is an Apple Watch app that will only be available by prescription.

The FDA has just approved the first coronavirus-specific antibody treatment for moderate cases of COVID-19. The focused Emergency Use Authorization (EUA) is aimed at newly diagnosed infections at the highest risk of progressing to severe disease.

An experimental drug has been shown to slow the progression and prolong survival of patients suffering from the neurodegenerative disease ALS. With Phase 2 human trials complete, the company developing the treatment is working to accelerate its approval.

A new experimental drug could help mitigate some of the dangerous side effects caused by a once-promising diabetes medication. Animal tests suggest the combination treatment is both safe and effective at helping regulate blood sugar levels in diabetics.

The FDA has approved two new kinds of breast cancer treatments, one targeting HER2-positive cancers and a second for metastatic triple-negative breast cancer. The approval for both treatments was expedited due to the novel coronavirus pandemic.

After a year of investigation the US Food and Drug Administration (FDA) has completely withdrawn all ranitidine products from the American market. Studies have revealed levels of a carcinogenic compound can increase in the product over time, particularly when stored at high temperatures.

“Use it or lose it” applies to muscles, but unfortunately so does “don’t use it too much or lose it.” Now, researchers at Temple University have tested a drug that appears to reverse muscle damage from overuse injuries in rats.

After a decade of legal and political battles, the FDA finally issued a conclusive new ruling for warnings on cigarette packs. The 11 new labels will fill 50 percent of the package with text and graphic imagery depicting the consequences of smoking.

Colloidal silver, herbal supplements and essential oils are among a number of products currently being fraudulently promoted as cures for COVID-19, as the US Food and Drug Administration targets seven companies peddling unproven treatments.