FDA

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.

The ALS Association is petitioning the FDA to forego Phase 3 trial requirements so the new drug can be put on the market immediately

Health & Wellbeing

Experimental ALS drug prolongs survival in Phase 2 human trial

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.

The new molecule is hoped to reduce the side effects of rosiglitazone, offering diabetics a novel and safe therapy

Science

Experimental molecule may reduce side effects of controversial diabetes drug

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 approval of two new treatments for breast cancer were expedited by the FDA to help high-risk populations during the coronavirus pandemic

Medical

FDA expedites approval of two new breast cancer treatments

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.

Ranitidine has been found to over time, and under certain environmental conditions, degrade into a carcinogenic chemical

Health & Wellbeing

FDA pulls common heartburn drug from US market after carcinogen concerns

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.