FDA'nın bağımsız uzman danışma kurulu, Moderna'nın mRNA teknolojisiyle geliştirdiği yeni grip aşısı mFlusiva için olumlu görüş bildirdi. Aşı, 50-64 yaş arası yetişkinlerde tam onay, 65 yaş ve üstü kişilerde ise kullanım izni için değerlendirilecek. Nihai karar ağustos başına kadar bekleniyor.
The FDA's vaccine advisory committee unanimously recommended Moderna's mRNA flu vaccine, mFlusiva, for adults 50 and over. This marks a significant step, potentially being the first vaccine approved under the second Trump administration despite past vaccine criticism from President Trump and HHS Secretary Robert F. Kennedy Jr.
FDA advisors voted 9-0 to approve Moderna's mRNA flu vaccine (mFlusiva), showing 27% greater efficacy than standard shots. The vaccine, developed on the same platform as COVID-19 vaccines, faced initial resistance from a Trump appointee but ultimately gained unanimous support.
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.
The FDA has cleared a second carcass-feasting fly species, Lucilia cuprina, for maggot wound therapy. Cuprina Holdings now holds FDA clearance for two species, aiming to dominate the global maggot market.
UniQure plans to seek FDA accelerated approval for its Huntington's disease gene therapy, using three-year data from a Phase 1/2 study. This follows a recent FDA meeting that reversed previous criticisms of the evidence, with shares soaring 70%.
A gene therapy for Huntington's disease, AMT-130, has a renewed path to FDA approval after the departure of Vinay Prasad, who had previously blocked the therapy's accelerated approval process. The FDA has once again agreed that UniQure can pursue approval with trial data using standard care patients as controls, avoiding sham surgeries.
Cooperativismo agora é manifestação cultural nacional e acessa fundos de desenvolvimento regional (FDNE, FDA, FDCO). Novas leis garantem apoio estatal e ampliam financiamento para projetos produtivos, fortalecendo o setor.
에이비엘바이오의 항암제가 FDA 패스트트랙으로 지정되면서 코스닥 바이오주에 훈풍이 불고 있다. 코스닥 지수도 반등하며 강보합권에서 움직이고 있으며, 정부의 코스닥 활성화 정책에 대한 기대감도 높아지고 있다.
에이비엘바이오의 이중항체 면역항암제 '지바스토미그'(ABL111)가 미국 FDA로부터 위암 1차 치료제로 패스트트랙 지정을 받았습니다. 이는 중증 질환 개발을 가속화하는 제도입니다.
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.
Peptídeo GHK-Cu, associado à regeneração da pele, ganha popularidade injetável em redes sociais. Especialistas alertam que a versão injetável não é aprovada para uso humano no Brasil ou EUA, com riscos de saúde e falta de controle regulatório.
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.
Cơ quan Quản lý Thực phẩm và Dược phẩm Mỹ (FDA) yêu cầu Nara Organics tự nguyện thu hồi 16 lô sữa bột công thức hữu cơ trên toàn quốc sau khi 3 trẻ sơ sinh nhập viện vì nhiễm độc tố botulinum.
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.
The US FDA has issued an import alert for Dabur India's factory in Dadra and Nagar Haveli, India, due to significant data integrity and maintenance lapses, including falsified manufacturing records and unsanitary conditions.
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.
The FDA's investigation into a botulism outbreak linked to ByHeart's infant formula, which sickened 48 infants across 17 states, failed to determine the source or root cause of contamination despite tracing the bacteria to ingredients. Three companies involved (ByHeart, Organic West, Dairy Farmers of America) deny responsibility.
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.
Taiwan's FDA is planning new regulations to restrict functional claims for 17 health food ingredients, requiring product registration and adherence to approved wording to combat misleading marketing and enhance transparency.
Pune FDA seized 16 tonnes of jaggery, 20 tonnes of sugar, and 68 kg of artificially colored fried green peas during raids. Adulterated flour, hoarded areca nuts, and banned gutka products were also confiscated. Three establishments received stop-work notices.
Taiwan's FDA is proposing amendments to the Pharmaceutical Affairs Act to combat illegal online drug sales. The changes would empower authorities to use technology for online patrols and require internet providers to block or remove illegal content within 24 hours, retaining data for 180 days. Non-compliance could result in fines of NT$200,000 to NT$5 million.
Um novo medicamento, daraxonrasib, dobrou a sobrevida mediana de pacientes com câncer de pâncreas metastático em estudo de fase 3, reduzindo o risco de morte em 60% e apresentando baixa toxicidade. Os resultados foram apresentados na ASCO e devem levar à aprovação regulatória nos EUA.
Wockhardt's novel antibiotic Zaynich (cefepime and zidebactam) has received US FDA approval for treating complicated urinary tract infections (UTIs), including pyelonephritis, caused by resistant microorganisms. It also gained approval in India for UTIs and concurrent Gram-negative bacteremia, addressing the growing antimicrobial resistance threat.
