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.
FDA Approval for Pfizer's Breast Cancer Drug: Vepdegestrant
The FDA has granted approval for Pfizer and Arvinas' novel breast cancer drug, vepdegestrant. This marks a significant new treatment option for patients with advanced or metastatic HR-positive, HER2-negative breast cancer who have exhausted prior endocrine therapies.
Auvelity FDA Approval: New MDD Treatment Option
The FDA has approved Auvelity, a new oral treatment for major depressive disorder (MDD) in adults, marking a significant advancement in mental health therapeutics. Manufactured by Axsome Therapeutics, this approval offers a novel option for patients seeking relief from MDD.
COFEPRIS Drug Approvals 2026: Regulatory Modernization and Market Impact
Explore the implications of COFEPRIS drug approvals in 2026, highlighting regulatory changes and their impact on the market for key medications like XYZ for diabetes.
SFDA expedited review oncology: What You Need to Know
Learn about the SFDA's expedited review for oncology drugs, including [Drug Name], designed to fast-track approvals and improve patient access to essential cancer therapies.
ANVISA Approves New Cannabis Framework & MagicTouch Device: Market Impact
The recent ANVISA approval of a new cannabis framework and the MagicTouch device marks a significant advancement in pain management solutions in Brazil.
COFEPRIS Drug Approvals 2026: What You Need to Know
Stay informed about COFEPRIS drug approvals in 2026, featuring essential insights on innovative treatments for diabetes and hypertension.
Plozasiran TGA Approval: REDEMPLO® Expands FCS Access in Australia
Arrowhead Pharmaceuticals has secured TGA approval for REDEMPLO® (plozasiran) in Australia, marking a significant step in providing a new treatment option for patients with Familial Chylomicronemia Syndrome (FCS). This approval broadens global access to plozasiran for this rare genetic disorder.
Mounjaro FDA Approval: Eli Lilly's Tirzepatide Milestone
Eli Lilly's tirzepatide, marketed as Mounjaro, has achieved FDA approval, marking a significant regulatory milestone. This dual GIP and GLP-1 receptor agonist is now more accessible for type 2 diabetes treatment in the US.
Mounjaro FDA Approval Obesity: Eli Lilly's Tirzepatide Awaits
Eli Lilly's Mounjaro (tirzepatide) is poised for a significant label expansion, seeking FDA approval for obesity and cardiovascular risk reduction. This potential approval could reshape the weight management and cardiovascular health markets.
Osimertinib FDA Approval Expands Early-Stage NSCLC Treatment
The FDA has approved osimertinib (Tagrisso) for adjuvant treatment of early-stage NSCLC, marking a milestone for AstraZeneca and expanding treatment options. Learn about the clinical data, market impact, and investment implications.
FDA Approvals NSCLC 2025: Market Impact & New Treatment Options
Discover the latest FDA approvals for NSCLC in 2025, focusing on new treatment options like XYZ Drug and their significant market implications.
FDA Approval of Elarekig: What You Need to Know
Elarekig has received FDA approval for advanced melanoma treatment, offering new hope for patients. Find out essential details about this breakthrough therapy.