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FDA Approval

FDA Approves First Oral PCSK9 Pill, Merck’s Lipfendra

Phase 3 trials showed roughly 56–59% reductions in LDL cholesterol and the pill will carry a $315 monthly list price.

FDA Approves Revtorpyk for HER2‑Low Breast Cancer but Launch and Safety Questions Loom

FDA Clears All-Oral Decitabine/Cedazuridine Plus Venetoclax for Older AML Patients

FDA Approves Bizengri for NRG1 Fusion Cholangiocarcinoma Under Accelerated Pathway

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

FDA Clears Dupixent as First Biologic for Young Children With Chronic Spontaneous Urticaria

GLP-1 Pills Accelerate into U.S. Care with Amazon Rollout and New Evidence on Use and Response

FDA Clears Eli Lilly’s Foundayo Oral GLP-1 for Weight Loss, With U.S. Launch Set for April 6

FDA Clears Lilly’s Foundayo Pill, Escalating GLP-1 Weight-Loss Rivalry

Novo Nordisk Launches Wegovy Weight‑Loss Pill in U.S. at $149 Starter Price

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

FDA Approves Cytokinetics’ Myqorzo for Obstructive Hypertrophic Cardiomyopathy

FDA Fast-Tracks Augmentin XR in First Approval Under National Priority Voucher Pilot

FDA Grants Full Approval to Jaypirca for Relapsed CLL/SLL After Covalent BTK Therapy

FDA Approves Novartis’ Itvisma for SMA Patients Ages 2 and Up

FDA Approves Epkinly Monotherapy and Triplet Regimen for Relapsed Follicular Lymphoma

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

FDA Grants Accelerated Approval to Forzinity, First Therapy for Barth Syndrome

FDA Approves Ionis’ Dawnzera to Prevent Hereditary Angioedema Attacks

Sotatercept cuts risk of death and hospitalization by 76% in advanced pulmonary arterial hypertension