Regulatory Updates

FDA Device Guidance Agenda: Key Regulatory Updates for 2026

FDA · 3 min

Lunai Bioworks and BrainStorm Therapeutics Launch AI Collaboration for Parkinson's and Rare Epilepsy

Parkinson's disease · 2 min

MannKind's Pediatric Expansion: A Game Changer for Afrezza Sales

FDA · pediatric diabetes · 4 min

Replimune's Third Attempt at Cancer Drug Approval: Insights from FDA Talks

FDA · cancer · 3 min

Regulatory Actions in May 2026: Key Updates for Pharma

2 min

AI and Brain Organoids Combat Parkinson's and Rare Epilepsy

Parkinson's disease · 3 min

Zydus Therapeutics' Saroglitazar Receives FDA Priority Review

FDA · 3 min

PharmTech’s Regulatory Roundup for May 2026: Drug Approvals

3 min

Bizengri Receives FDA National Priority Nod for Rare Bile Duct Cancer

FDA · rare bile duct cancer · 2 min

FDA Commissioner Resignation and Its Impact on Drug Approvals

FDA · 3 min

States Confront Medical Chatbots Oversight Amid FDA Inaction

FDA · 3 min

AI Breast Cancer Risk Prediction Tool Gains FDA Approval

FDA · oncology · 3 min