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Vanrafia (Atrasentan) Earns FDA Approval for IgAN, Achieved Proteinuria Reduction

XTalks

Primary IgAN is a rare autoimmune disease in which deposits of IgA provoke glomerular inflammation and excessive protein leakage into the urine. Vanrafia is expected to be available through specialty pharmacies and nephrology clinics across the US later this quarter.

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Acute Leukemia Drug Revuforj Wins FDA Approval, Second Approval for Syndax this Year

XTalks

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

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Roche takes on pricey rivals as FDA approves SMA drug

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Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

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Merck’s Winrevair Wins FDA Approval as First-in-Class Treatment for Pulmonary Arterial Hypertension (PAH)

XTalks

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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FluMist Takes Flu Protection Home: FDA Approves Self-Administration

XTalks

However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine. The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations.

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TNKase (Tenecteplase) Becomes First Stroke Medicine Approved by FDA in Almost 30 Years

XTalks

Pricing data indicate that the price of TNKase is around $8,672 for a 50 mg IV injection for cash-paying customers, though prices can vary based on pharmacy and location. TNKase works by initiating a biochemical reaction that breaks down fibrin, a protein that acts like the scaffolding holding blood clots together.

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Top 20 Best-Selling Neurology Drugs to Watch in 2024

XTalks

Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. mL, depending on the pharmacy. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1. mL) is around $620 for a supply of 0.25