Welcome to HCPFIVE, your go-to roundup for the latest healthcare news and breakthroughs is specifically curated for busy health professionals.
Each week, we highlight five important developments or headlines from healthcare that you need to know. Whether it's cutting edge treatment, regulatory updates, or innovations that will shape the future of medicine. This week's top stories included five new important decisions by the U.S. Food and Drug Administration (FDA), including the first new stroke drug approved for nearly 30 years, a general formulation of common anticoagulants that receive green light, an enlarged sign of an allergy-centric nasal spray, and an expansion of the treatment of neurodegenerative reticulum (Chrney dided in themed in themed in themed chidded in themed ectinced chidded).
Using HCPFIVE gives you important points to provide information and stay in front of the curve. You can easily dive into the top stories of the week of March 2nd, 2025.
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FDA approves tenectase (TnKase) for acute ischemic stroke
The FDA approved Genentech's tenectase (TnKase) for the treatment of adults with acute ischemic stroke (AIS), and in nearly 30 years it became the first stroke care approved by regulators. Tenecteplase, tissue plasminogen activator, coagulation, and thrombolytics are administered as a single 5-second intravenous (IV) bolus. Genentech has announced plans to introduce a 25 mg vial configuration to support this approval.
FDA approves CAD, PAD's first generic rivaloxaban (Xarelto)
The first common formulation of Rivaroxaban (Xarelto) 2.5 mg tablets received approval to reduce cardiovascular risk in adults with coronary artery disease (CAD) and reduced thromboembolic risk in adults with peripheral artery disease (PAD). Anticoagulants containing ribaroxaban are frequently prescribed in the United States, and this general approval directly affects patients who rely on these drugs.
FDA Approves 1 mg Neffy Nasal Spray for Children's Anaphylaxis
ARS Pharmaceuticals has announced approval for 1 mg of epinephrine nasal spray (Neffy) for the treatment of type 1 allergic reactions in patients between the ages of 15 and <30 kg, including patients aged 4 and over. This approval was awarded within seven months of Neffy's historic approval for adults and children weighing over 30 kg. By May 2025, the availability of a new 1 Mg formulation is expected.
FDA approves Mactel's Revakinagene Taroretcel (enselto)
Neurotech Pharmaceuticals received regulatory approval for Revakinagene Taroretcel-Lwey (Encelto), once known as NT-501, and treated macular capillary Ectasia type 2 (Mactel). This green light marked the first and only FDA-approved treatment for MacTel, a retinal neurodegenerative disease that can cause progressive and irreversible vision loss.
FDA approves furosemide injection (Furoscix) for edema of CKD
The regulator has approved a supplemental new drug application (SNDA) for furosemide (furosix) Scpharmaceuticals and expanded the indications of the drug to include the treatment of edema in patients with chronic renal disease (CKD). Furosemide injection, 80 mg/10 ml for subcutaneous use, is currently approved for treating edema including congestion, fluid overload, or hypertension in adults with CKD, including chronic heart failure or renal syndrome.
