HeyJaredRyan Livingston
- Indexed articles, last 90 days
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- Sep 30, 2026
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- Sep 28, 2026
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FDA Approves Mavacamten for Pediatric Patients With Obstructive HCM | HCPLive (opens the original)
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Mavacamten is approved to improve functional capacity and symptoms in adults and pediatric patients weighing at least 30 kg with symptomatic oHCM. Mavacamten is a selective, reversible, allosteric cardiac myosin inhibitor targeting hypercontractility, which reduces LVOT obstruction and lowers cardiac filling pressures. In 44 adolescents with symptomatic oHCM, mavacamten reduced Valsalva LVOT gradient by 48.0 mm Hg more than placebo at week 28 (P < .0001), with no patient developing LVEF below 50
FDA Approves Labeling Update for iDose TR for Open-Angle Glaucoma and Ocular Hypertension | HCPLive (opens the original)
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Drug: iDose TR (travoprost intracameral implant) Class: Prostaglandin analog, sustained-release intracameral therapy Indication: Reduction of intraocular pressure in open-angle glaucoma or ocular hypertension Regulatory Action: FDA approval of labeling supplement allowing repeat administration Key Evidence: Phase 3 and phase 2b trials showing favorable corneal endothelial safety through 3 years; 12-month safety data from an implant exchange study Key Safety Signals: Iritis, ocular hyperemia, inc
Zilurgisertib Receives FDA Approval for FOP in Patients 12 and Older | HCPLive (opens the original)
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Key TakeawaysThe FDA approved zilurgisertib (Atebrioz), an oral ALK2 inhibitor, for FOP in patients aged 12 years and older, making it the third approved FOP therapy.In PROGRESS, total new HO volume fell by a mean of 3.2 cm³ with zilurgisertib vs a 24.6 cm³ increase with placebo at week 24.The prespecified primary endpoint, proportion of patients with new HO lesions, showed an 81% relative reduction but did not reach statistical significance (P = .0986).No AEs led to discontinuation or dose redu
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