FDA advisers are meeting for two days to review evidence for seven experimental peptide therapies, including TB-500, BPC-157, and MOTs-C, to determine if they can be compounded by specialized pharmacies despite FDA scientists' recommendations against approval due to limited human data.
The FDA's Pharmacy Compounding Advisory Committee meets Thursday for two days to recommend on allowing compounding pharmacies to make popular injectable peptides like TB-500 and BPC-157. This decision is critical amidst safety concerns, lack of large-scale human trials, and industry pressure to lift current restrictions.
US officials reported a false positive for cyclospora in an iceberg lettuce sample from Taylor Farms, initially linked to a diarrhoea outbreak affecting thousands. The exact source remains unknown, but Taylor Farms voluntarily removed central Mexico-sourced lettuce, and Taco Bell stopped serving it in five states.
A sample of Taylor Farms iceberg lettuce tested positive for Cyclospora, linked to a US diarrhoea outbreak affecting thousands, hospitalizing 94. The FDA investigates, while Taylor Farms voluntarily removed central Mexico-sourced lettuce. CDC advises against Taco Bell's shredded iceberg lettuce in five states.
Experts claim the FDA is underprepared to handle infant formula contamination threats due to staff cuts from the Trump administration. Recalls due to bacterial contamination have increased, with states taking on more regulatory responsibility.
US health advisers are reviewing Moderna's new mRNA flu vaccine, mFlusiva, for individuals 50 and older. The vaccine, similar to those used for COVID-19, showed a 27% reduction in flu cases in a study. The FDA is assessing its safety and efficacy, with a decision expected before the winter flu season.
O reposicionamento de medicamentos, que consiste em encontrar novos usos para fármacos já existentes, tem se mostrado uma estratégia eficaz e econômica para salvar vidas, especialmente em crises de saúde como a da COVID-19. Medicamentos como a dexametasona e o baricitinibe foram reaproveitados para tratar a inflamação em pacientes com coronavírus, salvando milhares de vidas. A Comissão Europeia planeja expandir essa abordagem para a busca de tratamentos contra o câncer. Exemplos históricos incluem o raloxifeno para prevenção de câncer de mama, a talidomida para mieloma múltiplo e o Viagra (sildenafil) para disfunção erétil, originalmente desenvolvido para doenças cardiovasculares. A tendência de reaproveitamento de medicamentos levanta questões sobre seus verdadeiros prós e contras, cujas respostas podem levar anos para serem totalmente compreendidas.
Novas diretrizes médicas nos EUA e Brasil priorizam semaglutida e tirzepatida para obesidade, com foco em mudanças de estilo de vida. Documentos organizam drogas por hierarquia e risco cardiovascular, visando melhorar saúde e reduzir mortalidade.
The FDA has approved bemotrizinol, a new chemical UV filter for sunscreens, for the first time in nearly 30 years. Dermatologists are cheering the ingredient's broad-spectrum UVA/UVB protection, photo stability, and safety profile, which could lead to better, more aesthetically pleasing sunscreens.
US regulators are warning consumers about potential kidney problems linked to GSK's Alli weight loss pill. The FDA identified 12 cases of kidney complications and advises those with kidney history to consult a doctor.
Um teste de sangue para rastrear múltiplos tumores, o NHS-Galleri, não reduziu casos avançados de câncer no Reino Unido, mas detectou mais tumores em estágio inicial e menos em estágio 4, indicando potencial para detecção precoce.
Dr. Tracy Beth Hoeg, an FDA official who led investigations into antidepressants, vaccines, and other therapies, has been removed from her role as acting director of the agency's drug program. Her departure follows a series of leadership changes at the FDA amid criticism from various groups.
Dr. Marty Makary resigned as FDA Commissioner after 13 months, marked by controversy over vaccine approvals, abortion drug policies, and regulatory clashes. President Trump praised Makary and announced Kyle Diamantas as acting head.
Dr. Marty Makary to resign as FDA commissioner amid tumultuous tenure and pressure from the White House over flavored e-cigarette sales
Utz issues voluntary recall for certain varieties of Zapp’s and Dirty potato chips over contamination linked to seasoningSign up for the Breaking News US newsletter emailUtz has issued a voluntary US recall of two potato chip brands after concerns that they could be contaminated with salmonella, a type of bacteria that can lead to food-borne illness.Certain varieties of Zapp’s and Dirty potato chips may contain contamination linked to the seasoning used on the products, according to the US Food and Drug Administration in a recall issued on Monday. The recall applies to three flavors of Zapp’s chips sold in various bag sizes, along with three flavors of Dirty chips packaged in 2-ounce bags. Continue reading...
The Food and Drug Administration said on Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression, the latest indication of the Trump administration’s commitment to the experimental treatment approach. President Donald Trump signed an executive order last weekend directing the FDA and other federal agencies to speed access and loosen restrictions on psychedelics, a class of hallucinogenic drugs which remain illegal...
