FDA

A patient undergoing MDMA treatment in one of the Phase 2 clinical trials

Health & Wellbeing

First Phase 3 trial data for MDMA therapy sets path for approval

The first results from Phase 3 trials testing MDMA-assisted psychotherapy for PTSD have been announced. The promising data are the first Phase 3 results to be revealed for any psychedelic-based therapy paving the way for a landmark FDA approval in 2023.

Unlabeled stimulants, including one originally developed in the 1940s and prohibited for half a century, have been found in various supplements

Health & Wellbeing

Experimental stimulants common in weight loss and sport supplements

A striking new study testing a number of over-the-counter weight loss and sports supplements has found they contain many combinations of stimulants that have either previously been prohibited by the FDA or never approved for human consumption.

Researchers are calling for greater surveillance from health authorities of the influence of food additives on immune system activity

Health & Wellbeing

Concerns raised over safety of common food preservative

A study is questioning the safety of a food preservative found in hundreds of products that is suspected of impairing immune system activity. The research calls for greater surveillance of the immunological effects of food additives.

A third COVID-19 vaccine has received emergency use authorization by the FDA

Health & Wellbeing

First single-shot, "fridge stable" COVID-19 vaccine approved in US

The FDA has approved a third COVID-19 vaccine for emergency use in the United States. Unlike the first two vaccines approved for use, this one is proven effective after only a single dose, and it can be safely distributed in standard refrigerator temperatures.

New data suggests Pfizer's COVID-19 vaccine is stable for at least two weeks under normal freezer temperatures

Health & Wellbeing

Pfizer reduces ultra-cold requirements for its COVID-19 vaccine

New data submitted to the U.S. Food and Drug Administration suggests Pfizer's COVID-19 vaccine is stable for two weeks in freezers around -15 °C (5 °F), allowing for significantly more flexibility in shipping and storage methods.

UK authorities have announced they will allow up to 12 weeks between the first and second COVID-19 vaccine doses but US regulators are calling this strategy risky and unproven

Health & Wellbeing

US and UK diverge over critical COVID-19 vaccine dose strategy

Health authorities in the UK have recommended extending dosing schedules for COVID-19 vaccines, claiming one dose offers short-term protection despite trials only testing two-dose regimes. US authorities call the change risky and unproven.

Despite FDA approval there are no immediate plans for genetically modified pig meat to be commercially sold in supermarkets

Biology

FDA approves first genetically modified pig for food and medical use

The US Food and Drug Administration has approved a genetically modified pig for human consumption and therapeutic use. The pig is engineered to be free of a certain sugar molecule responsible for severe allergic reactions in some people.

Moderna's final efficacy analysis concluded its vaccine is 94.1 percent effective at preventing disease

Health & Wellbeing

Moderna says vaccine prevents severe COVID-19, files for FDA approval

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.

Emergency Use Authorization will be submitted to the FDA in days for a COVID-19 vaccine developed by Pfizer and BioNTech

Health & Wellbeing

Pfizer reports COVID-19 vaccine 95% effective as Phase 3 trial concludes

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.

Results of a phase 2 clinical trial of a cholesterol-reducing drug called evinacumab have been promising

Medical

Experimental drug halves cholesterol levels in phase 2 clinical trials

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.

A new prescription-only system uses an Apple Watch to detect and disrupt nightmares through gentle vibrations without waking the user

Medical

FDA approves prescription-only Apple Watch app for PTSD nightmares

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's limited emergency approval focuses on high-risk patients in the first 10 days of COVID-19 symptoms appearing

Health & Wellbeing

FDA grants emergency approval to experimental COVID-19 antibody therapy

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.