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Primer On FDA’s "Breakthrough Therapy" Program

A look at the genesis of the US expedited regulatory pathway for drugs and biologics, its benefits, and how the program is working today.

The designation resulted, in part, from a November 2011 cancer research conference sponsored by the Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution. A panel of agency representatives and stakeholders discussed proposals for expediting the development of drugs with early evidence of large treatment effects. (See Also see "Expedited Approval Pathway Concept Draws Strong Support But Different Proposals" - Pink Sheet, 5 December, 2011..)

The concept of a progressive approval pathway also was included in the Biotechnology Industry Organization’s list of “big ideas” for...

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ADC Innovation: Record Funding Fuels Tubulis’s Clinical Push Into 2026

 
• By Lucie Ellis-Taitt

“Tubulis is not a single-asset company… It’s an innovation powerhouse,” said CEO Dominik Schumacher in an interview with In Vivo. He outlined the company’s clinical progress, funding momentum and how Tubulis will navigate the competitive biotech market in 2026.

Deals In Depth: October 2025

 
• By Maureen Riordan and Deanna Kamienski

Eleven $1bn+ alliances were penned in October, and four exceeded $2bn. In the top alliance by deal value, Innovent Biologics entered into a potential $11.4bn collaboration with Takeda to co-develop and commercialize next-generation immuno-oncology and antibody-drug conjugate cancer therapies.

Clinical Trial Roundup: Oncology Dominates, Cardiovascular Surges, Infectious Disease Declines

 
• By Shannon Fisher and Heidi Chen

In 2024, trial initiations shifted following the post-pandemic decline in COVID-19 studies. Cardiovascular trials showed the greatest growth by therapeutic area but trailed the previous year’s initiation levels.