FDA aprova o FILSPARI da Travere Therapeutics para a GESF

13 de abril de 2026

Reportado por IA

A Food and Drug Administration (FDA) dos EUA aprovou o FILSPARI, desenvolvido pela Travere Therapeutics, como o primeiro medicamento para a glomerulosclerose segmentar e focal (GESF). A Travere anunciou a aprovação em 13 de abril de 2026. Executivos da empresa realizaram uma conferência de atualização de negócios naquela noite para discutir o marco.

A Travere Therapeutics anunciou a aprovação do FILSPARI pela FDA para pacientes com GESF no dia 13 de abril de 2026. O medicamento marca o primeiro tratamento aprovado para essa condição renal, segundo a empresa. Um comunicado à imprensa e slides da apresentação estão disponíveis no site corporativo da Travere. A conferência contou com a liderança do presidente e CEO, Eric Dube, acompanhado pela diretora médica, Jula Inrig, e pelo diretor comercial, Peter Heerma, para observações preparadas. O diretor de pesquisa, William Rote, e o diretor financeiro, Chris Cline, participaram da sessão de perguntas e respostas. Analistas de firmas como Leerink Partners, JPMorgan Chase, Guggenheim Securities, Wedbush Securities, TD Cowen, Cantor Fitzgerald, Wells Fargo Securities, Jefferies, Citigroup, BofA Securities e Stifel participaram da chamada. Nivi Nehra, vice-presidente de comunicações corporativas e relações com investidores, iniciou os procedimentos.

Finerenone slows kidney decline in non-diabetic CKD trial; pooled analysis suggests broader benefits across CKD

08 de junho de 2026 Reportado por IA Imagem gerada por IA Verificado

New data presented at the European Renal Association’s 63rd Congress in Glasgow and published in three major medical journals found that finerenone slowed kidney-function decline in adults with chronic kidney disease (CKD) without diabetes and reduced the risk of a combined kidney-and-cardiovascular outcome. A separate pooled analysis that combined results across finerenone studies also reported fewer kidney and heart-failure events in a broader CKD population.

Syntara reports positive FDA feedback on amsulostat trial

Syntara Limited held a shareholder webinar on April 29 to discuss FDA feedback on its proposed Phase IIb trial for amsulostat in myelofibrosis, along with a capital raise and quarterly report. CEO Gary Phillips highlighted the agreed path forward with regulators. The company lodged its Appendix 4C quarterly with the ASX.

Health panel approves coverage for iPS cell-derived Parkinson’s disease treatment

13 de maio de 2026 Reportado por IA

A Japanese health panel has approved national health insurance coverage for Sumitomo Pharma's Amchepry, an iPS cell-derived treatment for Parkinson’s disease. The move makes it the world's first commercialized medical product from iPS cells.

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Caribou Biosciences presents car-t updates at healthcare conference

16 de maio de 2026 Reportado por IA

Caribou Biosciences discussed progress on its off-the-shelf CAR-T therapies during a presentation at the Bank of America Global Healthcare Conference on May 13. Chief executive Rachel Haurwitz highlighted Phase I data for two programs that target lymphoma and multiple myeloma.

domingo, 14 de junho de 2026, 20:53h