What Is a Companion Diagnostic?
Learn what a companion diagnostic is, why it matters for precision medicine, and how it affects biotech development and commercialization.
What Is an Exclusivity Period?
Learn what exclusivity period means in biotech, why it matters for commercialization, and how it protects drugs from competition.
What Is a Post-Marketing Study?
Learn what post-marketing studies are, why the FDA requires them, and how they affect biotech news after approval.
What Is Accelerated Approval?
Learn what accelerated approval means in biotech, why it matters for serious diseases, and how it depends on surrogate endpoints and post-marketing studies.
What Is Priority Review and Why Does It Matter?
Learn what priority review means at the FDA, why it matters for biotech approval timelines, and how it can shorten a review cycle.
What Is Fast Track Designation?
Learn what fast track designation means in biotech, why it matters for serious diseases, and how it can support a quicker development path.
What Is Breakthrough Therapy Designation?
Learn what breakthrough therapy designation means, why it matters in biotech, and how it can speed development and regulatory interaction.
What Is Orphan Drug Designation and Why Does It Matter?
Learn what orphan drug designation means, why it matters for rare disease biotech programs, and how it affects development and commercialization.
What Is an IND and Why Does It Matter in Drug Development?
Learn what an IND is, why it matters in biotech drug development, and how it signals the beginning of human clinical testing.