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Drug Approval

FDA FDA Approval FDA Regulations Regulatory Affairs FDA Approvals Semaglutide Anvisa NHS Treatments NHS Innovations EMA

FDA Approves Bizengri for NRG1 Fusion Cholangiocarcinoma Under Accelerated Pathway

The therapy becomes the first targeted option for this ultra-rare bile duct cancer subset.

FDA Expands Tzield Use to Delay Type 1 Diabetes in Children Ages 1 to 7

FDA Grants Accelerated Approval to Lilly’s Oral Weight-Loss Pill Foundayo

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Approves First Glucocorticoid Receptor Blocker for Platinum-Resistant Ovarian Cancer

FDA Approves Nivolumab Plus AVD as First-Line Therapy for Advanced Hodgkin Lymphoma

FDA Approves Breyanzi for Marginal Zone Lymphoma After Two or More Therapies

FDA Approves Komzifti, First Menin Inhibitor for Relapsed NPM1‑Mutant AML

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

Datroway Extends Survival Over Chemotherapy in First-Line TNBC Ineligible for Immunotherapy

FDA Approves Zoryve 0.05% Cream for Children Ages 2–5 With Mild to Moderate Atopic Dermatitis

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

FDA Approves Keytruda QLEX, a Rapid Subcutaneous Option for Most Adult Solid Tumor Uses

MHRA Approves GSK’s Blujepa for Uncomplicated UTIs, First New Oral Option in Nearly 30 Years

NICE Recommends Padcev–Keytruda as First-Line NHS Treatment for Advanced Bladder Cancer

Health Canada Approves Ozempic for Type 2 Diabetes With CKD to Slow Kidney Decline and Reduce Cardiovascular Death

FDA Approves Vizz Eye Drops to Treat Presbyopia

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer

FDA Approves First Systemic Therapy for H3 K27M-Mutant Diffuse Midline Glioma

EMA Recommends Donanemab for Early Alzheimer’s in the EU