Drug Approvals
Page 1 • 12 itemsTrack global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.
CRISPR Therapeutics' CASGEVY Reaches 60,000+ Eligible Patients Across 10 Countries Following Global Approvals
CRISPR Therapeutics reports CASGEVY now approved in 10 countries for severe sickle cell disease and beta thalassemia, reaching over 60,000 eligible patients worldwide.
Clene's CNM-Au8 Gets FDA Green Light for Accelerated Approval Pathway in ALS Treatment
FDA confirms Clene's CNM-Au8 ALS drug can proceed via accelerated approval pathway using neurofilament light biomarker data, with NDA filing expected Q3 2026.
Novartis Receives Health Canada Approval for Fabhalta Oral Treatment for C3G Patients
Health Canada approves Novartis' Fabhalta (iptacopan) oral treatment for adults with complement 3 glomerulopathy, offering new hope for rare kidney disease patients.
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Enters Diabetes Market
FDA approves LANGLARA as interchangeable biosimilar to Lantus insulin glargine, marking Lannett Company's entry into diabetes treatment market through Lanexa Biologics.
FDA Approves Guardant360 CDx as Companion Diagnostic for Pfizer's VEPPANU in ER+/HER2- Breast Cancer
Guardant Health receives FDA approval for Guardant360 CDx liquid biopsy test as companion diagnostic for VEPPANU (vepdegestrant) in advanced breast cancer patients.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis and Blood Disorders
Incyte receives FDA approval for once-daily Jakafi XR (ruxolitinib) extended-release tablets for myelofibrosis, polycythemia vera, and GVHD treatment.
Arvinas VEPPANU (Vepdegestrant) Receives FDA Approval as First PROTAC Drug for ESR1-Mutated Breast Cancer
Arvinas' VEPPANU becomes the first FDA-approved PROTAC drug for ESR1-mutated, ER+/HER2- advanced breast cancer, marking a breakthrough in protein degradation therapy.
FDA Approves Palazestrant for Breast Cancer Amidst Data Concerns
The U.S. Food and Drug Administration (FDA) has granted approval for palazestrant, a novel breast cancer treatment developed by Pfizer and Arvinas. This decision comes despite some concerns raised about the drug's clinical trial data, marking a significant development in breast cancer therapy.
NIKTIMVO (Axatilimab) Approved in Australia as First-in-Class Chronic Graft-Versus-Host Disease Treatment
Australia's TGA approves NIKTIMVO (axatilimab), a breakthrough first-in-class therapy for chronic graft-versus-host disease under priority review.
Axsome FDA Approval for Alzheimer's Agitation Drug
Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.
FDA Approves First Non-Antipsychotic for Dementia Agitation
The FDA has approved the first non-antipsychotic medication for agitation linked to dementia from Alzheimer's disease. This landmark approval provides a much-needed alternative to antipsychotics, which carry significant risks for this patient population.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis, Polycythemia Vera Treatment
Incyte receives FDA approval for Jakafi XR (ruxolitinib) extended-release tablets, offering improved dosing convenience for rare blood cancer patients.