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FDA vs EMA Orphan Drug Designation: Key Differences
Planning FDA and EMA orphan designations? Learn the key eligibility and strategy differences for efficient dual-region execution.
Kailee Johnson
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How Wegovy Became the First FDA‑Approved Oral GLP‑1 for Weight Management
In‑depth analysis of the FDA approval of the first oral GLP‑1 for weight management, examining formulation strategy, regulatory precedent, and implications for future oral peptide development.
Emily Weil
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Nonclinical Modernization: Reducing Animal Use
New approach methodologies (NAMs) are nonclinical tools that offer potential to improve biological relevance and predictive accuracy of safety and efficacy assessments, while...
Melissa Pegues, PhD
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How a Nonclinical Program Can Help Identify and Mitigate Risks
Transitioning a new drug candidate from discovery to the clinic is a significant leap, and a strong nonclinical development plan is critical to...
Melissa Pegues, PhD
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What is an IND?
An IND unlocks human testing - know what’s required and how early regulatory input can guide strategy.
Melissa Pegues, PhD
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Complete Response Letters and FDA Transparency – What Do We Know?
On 10 July 2025, FDA unexpectedly announced the release of over 200 complete response letters (CRLs) in an act they claimed embraced “radical...
Kailee Johnson