Business ❯ Pharmaceutical Industry

Regulatory Affairs

FDA Approvals Drug Approval FDA FDA Approval Drug Approval Process FDA Approval Process FDA Regulations European Medicines Agency Compliance Issues Drug Pricing Strategies Product Safety Quality Assurance Health Policy Workforce Management Transparency Initiatives Product Oversight FDA Advisory Panels Market Withdrawal Taxation Compliance Strategies Clinical Trials Patent Regulations Market Regulation Market Access Global Filings Patent Law FDA Designations Clinical Research EU Approval Market Authorization Digital Solutions Product Compliance Compliance Management

FDA Approves Juvmo as First D1/D5 Agonist for Parkinson’s Disease

The drug’s D1/D5 mechanism could slow patients’ need to raise levodopa doses, with U.S. availability scheduled for October 2026.

Novo Nordisk’s Semaglutide Eases Childhood Obesity as Heart-Drug Trials Are Halted

FDA Clears Wearable Injector Form of Sanofi’s Multiple Myeloma Drug

Ocular Therapeutix Plans Q4 Filing for AXPAXLI After Reported FDA Alignment

CHMP Recommends Adding Oral Wegovy Tablets to EU Approval

FDA Approves Langlara as Interchangeable Biosimilar to Lantus

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

FDA Grants Orphan Drug Status to Immutep’s Efti for Soft Tissue Sarcoma

CHMP Backs Xolremdi for WHIM Syndrome Under Exceptional Circumstances

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

FDA Seeks Removal of Suicide Warnings From Saxenda, Wegovy and Zepbound

Zenas' Obexelimab Meets Phase 3 Goals in IgG4-Related Disease With 56% Flare Risk Cut

FDA Adds Brain Tumor Warning to Two Depo‑Provera Injections

Gilead’s BIC/LEN HIV Tablet Matches Biktarvy in Phase 3 Switch Trial

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS

Yale Study Finds Only 24% of Medicines Tested Reach Trial-Host Countries Within Five Years

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions

Former FDA Biologics Chief Peter Marks Joins Eli Lilly to Lead Infectious Disease and Molecule Discovery

FDA to Publicly Release All Future Drug Rejection Letters, Posts 89 Recent CRLs

FDA Launches Coordinated Pathway to Review Therapies for Ultra-Rare Genetic Diseases