FDA Flags Potential Guillain-Barre Risk With RSV Vaccine Candidates
Ahead of a 2-day meeting with FDA’s vaccine advisors, reviewers at the agency highlighted a rare but potential risk for Guillain-Barré syndrome with two vaccine candidates for respiratory syncytial virus (RSV). On Tuesday and Wednesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will recommend whether the risk-benefit profile with Pfizer and GSK’s vaccine […]
FDA Authorizes At-Home Test for Both Flu and COVID
The FDA has authorized the first over-the-counter (OTC) home test to detect both influenza A and B and COVID-19, the agency announced Friday. The Lucira COVID-19 & Flu Test is a single-use at-home test kit that provides results in about 30 minutes. The test is designed for those with symptoms of a respiratory tract infection. […]
EPA Favors Stricter Air Quality Standards
The Environmental Protection Agency (EPA) wants to tighten the national annual limit on particulate matter (PM) pollution, according to its proposed updates to the National Ambient Air Quality Standards (NAAQS) for Fine Particulate Matter. Part of the EPA’s plan is to lower the primary (health-based) annual PM2.5 standard down to 9.0-10.0 µg/m3, compared with the […]
WHO ‘Very Concerned’ About Reports Of Severe COVID In China
GENEVA (AP) — The head of the World Health Organization said the agency is “very concerned” about rising reports of severe coronavirus disease across China after the country largely abandoned its “zero COVID” policy, warning that its lagging vaccination rate could result in large numbers of vulnerable people getting infected. At a press briefing on […]
FDA Advisors Back Fecal Microbiome Treatment for Recurrent C. Diff
An FDA advisory board recommended the agency approve a fecal microbiota transfer (FMT) product for recurrent Clostridium difficile infections. By a vote of 13-4 on Thursday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), said RBX2660 was effective for treating patients with recurrent C. diff infections who failed first-line antimicrobial therapy. Safety landed in […]
Long-Denied COVID Vax Lands Authorization
As expected, the FDA has granted an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced on Wednesday. The decision follows a near-unanimous FDA advisory committee recommendation more than a month ago, with the EUA reportedly delayed in order to allow regulators time to review recent changes to the vaccine’s manufacturing […]
WHO Official: COVID Outbreak In North Korea Is Likely ‘Getting Worse, Not Better’
LONDON (AP) — A top official at the World Health Organization said the U.N. health agency assumes the coronavirus outbreak in North Korea is “getting worse, not better,” despite the secretive country’s recent claims that COVID-19 is slowing there. At a briefing on Wednesday, WHO’s emergencies chief Dr. Mike Ryan appealed to North Korean authorities […]
First GLP-1/GIP Receptor Agonist OK’d for Type 2 Diabetes
The FDA approved first-in-class tirzepatide (Mounjaro) for patients with type 2 diabetes, the agency announced on Friday. Tirzepatide, a glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonist, is available at three dose levels (5 mg, 10 mg, and 15 mg), should be administered via injection once weekly, and is indicated as an adjunct to diet […]
99% Of World’s Population Breathes Poor-Quality Air: WHO
GENEVA (AP) — The U.N. health agency says nearly everybody in the world breathes air that doesn’t meet its standards for air quality, calling for more action to reduce fossil-fuel use, which generates pollutants that cause respiratory and blood-flow problems and lead to millions of preventable deaths each year. The World Health Organization, about six […]
FDA Greenlights First Condom Specifically for Anal Intercourse
The first condoms specifically indicated for use during anal sex gained a thumbs up from the FDA, the agency announced on Wednesday. One Male Condoms, manufactured by Global Protection of Boston, received marketing authorization to prevent sexually transmitted infections (STIs) during anal intercourse, including HIV. The move could improve public health efforts to reduce STIs, […]