Vanda Pharmaceuticals Inc. (VNDA), Monday announced that the company has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration for imsidolimab to treat generalized pustular psoriasis, a rare, chronic autoinflammatory skin disorder. The application is backed by positive...
A federal vaccine advisory committee has decided to stop recommending hepatitis B vaccinations for all newborns, marking a significant change from the U.S. public health policy that's been in place for decades.
The U.S. Food and Drug Administration (FDA) is considering adding a "black box" warning, its strongest type of safety alert, to COVID-19 vaccines, according to a CNN report. It further noted that the idea is being pushed by Vinay Prasad, the FDA's top vaccine official. Notably, a black box warning...
Cytokinetics, Inc. (CYTK), Friday announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for MYQORZO, also known as aficamten, in the European Union for the patients with symptomatic...
The U.S. Food and Drug Administration has announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens. Based on the data...
New analysis from the World Health Organization's global expert committee on vaccine safety has found that, based on available evidence, there is no link between vaccines and autism spectrum disorders, or ASD. The conclusion reaffirms WHO's position that childhood vaccines do not cause autism. The...
Health officials in South Carolina shared that the measles outbreak in the state is getting worse, with no signs of slowing down after Thanksgiving and other large gatherings. As of Wednesday, 111 cases have been reported in the upstate region, which includes Greenville and Spartanburg, with 27 new...
Researchers from around the world have found new clues about why many people have more than one psychiatric disorder at the same time. In a large study, published in Nature, they examined the shared genetic roots of 14 mental health conditions, including depression, anxiety, schizophrenia, bipolar...
AC Immune SA (ACIU), Thursday announced positive interim safety and efficacy results from the Phase 2 VacSYn trial of anti-alpha-synuclein active immunotherapy ACI-7104.056 in early Parkinson's disease. The findings noted that ACI-7104.056 induced a robust antibody response against the immunizing...
The Centers for Disease Control and Prevention has urged parents to stop using any ByHeart Whole Nutrition infant formula immediately, even if it is mistakenly found for sale in stores or online. Laboratory tests have shown that the formula is contaminated with botulism spores and can make infants...
A large study covering nearly half of France's population found that young and middle-aged adults who received mRNA COVID-19 vaccines were 74 percent less likely to die from COVID-19 than those who were not vaccinated. Surprisingly, vaccinated people were also 25 percent less likely to die from any cause...
A new study revealed that children who spend a lot of time on social media may have more trouble concentrating and could be more likely to develop symptoms of ADHD. Researchers from the Karolinska Institutet followed more than 8,000 U.S. children from ages 9-10 to 14. The children reported how much...
The European Commission and the World Health Organization have signed a 3.5 million EURO agreement under the EU4Health program to strengthen the global response to antimicrobial resistance. This partnership will support the WHO in monitoring the development of antimicrobials and medical countermeasures,...
The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of a rare, genetic immune disorder Wiskott-Aldrich syndrome, or WAS. Waskyra is indicated for pediatric patients six months and older and adults with WAS who...
The U.S. Food and Drug Administration has approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application. "Over the last few decades, America l
December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.