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EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

US FDA Looks To Standardize Premarketing Safety Assessments

How To Pay For The New Wave Of Gene Therapies

Roche: We’ve Abandoned Budgets And It’s Liberated Employees

Novo Nordisk’s Oral Rybelsus Priced On Par With Injectable GLP-1s, But Big Discounts May Be Needed

ESMO Preview: Five Key Oncology Battlegrounds To Watch

Farxiga Data Change Heart Failure Treatment Outlook

How To Pay For The New Wave Of Gene Therapies

Testing Ranitidine with Too Much Heat Could Generate NDMA, FDA Say

Anti-Aging Cosmetics Or Unlawfully Marketed Drugs? Two Federal Court Cases To Watch

Serious Skin Reactions Reported with Ibuprofen Use in Europe

A Hangover Is A Disease, German Court Rules