FDA menyetujui FILSPARI dari Travere Therapeutics untuk FSGS

Senin, 13 April 2026

Dilaporkan oleh AI

Badan Pengawas Obat dan Makanan (FDA) AS menyetujui FILSPARI, yang dikembangkan oleh Travere Therapeutics, sebagai obat pertama untuk fokal segmental glomerulosklerosis (FSGS). Travere mengumumkan persetujuan tersebut pada 13 April 2026. Para eksekutif perusahaan mengadakan panggilan konferensi pembaruan bisnis pada malam harinya untuk membahas tonggak pencapaian tersebut.

Travere Therapeutics mengumumkan persetujuan FDA atas FILSPARI untuk pasien FSGS pada awal 13 April 2026. Menurut perusahaan, obat ini merupakan perawatan pertama yang disetujui untuk kondisi ginjal tersebut. Siaran pers dan slide presentasi tersedia di situs web korporat Travere. Panggilan konferensi tersebut menampilkan Presiden dan CEO Eric Dube yang memimpin diskusi, didampingi oleh Chief Medical Officer Jula Inrig dan Chief Commercial Officer Peter Heerma untuk penyampaian pernyataan resmi. Chief Research Officer William Rote dan Chief Financial Officer Chris Cline berpartisipasi dalam sesi tanya jawab. Analis dari berbagai perusahaan termasuk Leerink Partners, JPMorgan Chase, Guggenheim Securities, Wedbush Securities, TD Cowen, Cantor Fitzgerald, Wells Fargo Securities, Jefferies, Citigroup, BofA Securities, dan Stifel turut bergabung dalam panggilan tersebut. Nivi Nehra, Wakil Presiden Komunikasi Korporat dan Hubungan Investor, membuka jalannya acara.

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

Senin, 08 Juni 2026 Dilaporkan oleh AI Gambar dihasilkan oleh AI Fakta terverifikasi

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

Rabu, 13 Mei 2026 Dilaporkan oleh AI

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.

Kesehatan

FDA approves Eli Lilly’s once-daily obesity pill Foundayo

Bisnis

Medartis hosts investor event in Basel on hand products

Eropa

SpectraCure launches rights issue to finance studies

Pemafibrate and telmisartan cut liver fat in MASLD animal models, study suggests

Researchers in Barcelona report that the lipid drug pemafibrate and the blood-pressure medicine telmisartan reduced diet-induced liver fat in rats and in a zebrafish model of fatty liver disease, with a half-dose combination performing as well as full doses of either drug alone. The work, published in Pharmacological Research, also describes a role for the PCK1 protein in telmisartan’s liver effects and argues that clinical trials would be needed to confirm any benefit in people.

Caribou Biosciences presents car-t updates at healthcare conference

Sabtu, 16 Mei 2026 Dilaporkan oleh AI

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.

14 Juni 2026 20.53