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FDA Approval

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

The ruling gives unfit, newly diagnosed patients a home-based alternative that still demands vigilant safety oversight.

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 Approves First Oral Wegovy Weight-Loss Pill as U.S. Availability Begins

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

FDA Approves Cytokinetics’ Myqorzo for Obstructive Hypertrophic Cardiomyopathy

Novo Nordisk Launches Ozempic in India With Weekly Starting Price of ₹2,200

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 Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

FDA Expands Revumenib Approval to NPM1-Mutant Relapsed/Refractory AML in Patients 1 and Older

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

FDA Approves Lilly’s Inluriyo for ESR1‑Mutated Advanced Breast Cancer