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FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page

Track global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.

Showing 493–504 of 665 articles

Critical impact NewsMay 3, 2026

FDA Approves First Non-Antipsychotic for Dementia Agitation

FDA · agitation associated with dementia due to Alzheimer's disease · 6 min

Dr. Grace Tan
Critical impact NewsMay 3, 2026

FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis, Polycythemia Vera Treatment

Hematology/Oncology · 3 min

Daniel Brooks
High impact AnalysisMay 3, 2026

Auvelity FDA Approval: New MDD Treatment Option

FDA · Major Depressive Disorder (MDD) · 12 min

Dr. Hannah O'Connor
Standard impact AnalysisMay 2, 2026

ANVISA Regulatory Changes: Key Impact on Foreign Drug Manufacturers in Brazil

ANVISA · 10 min

Dr. Amina Farouk
High impact AnalysisMay 2, 2026

ANVISA Approves New Cannabis Framework & MagicTouch Device: Market Impact

ANVISA · Medical Cannabis · 8 min

Dr. Yuki Tanaka
Standard impact AnalysisMay 2, 2026

COFEPRIS Drug Approvals 2026: What You Need to Know

COFEPRIS · 9 min

James Chen, PharmD
Standard impact AnalysisMay 2, 2026

ANVISA Clinical Trial Regulations: What Foreign Pharma Must Know in 2025

ANVISA · General Clinical Trials · 12 min

Dr. Priya Nandakumar
Critical impact NewsMay 2, 2026

Plozasiran TGA Approval: REDEMPLO® Now Available in Australia for FCS

TGA · Familial Chylomicronemia Syndrome (FCS) · 6 min

Dr. Elena Rossi
High impact NewsMay 2, 2026

Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity

Rare neuroendocrine diseases / Obesity · 3 min

Dr. Emily Carter
Critical impact NewsMay 2, 2026

Novo Nordisk's Oral Ozempic Becomes First FDA-Approved Pill GLP-1 for Type 2 Diabetes with Cardiovascular Protection

FDA · Type 2 diabetes with cardiovascular risk reduction · 3 min

James Chen, PharmD
Critical impact NewsMay 2, 2026

Axsome Therapeutics Receives FDA Approval for AUVELITY to Treat Alzheimer's Agitation - First-in-Class Breakthrough

FDA · Alzheimer's disease agitation · 3 min

Dr. Sarah Mitchell
Critical impact NewsMay 2, 2026

Arvinas Receives FDA Approval for VEPPANU (Vepdegestrant), First PROTAC Drug for ESR1-Mutated Breast Cancer

FDA · Oncology - Breast Cancer · 3 min

Michael Rivera