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2025 Drug Approval Review
Guests:
Peter Bak, MD, Partner, Managing Director
Mavra Nasir, MD, Director
Length: 28:34 minutes
Airdate: February 9, 2026
As the life sciences industry turns the page to 2026, Back Bay Life Science Advisors’ Dr. Pete Bak and Dr. Mavra Nasir take a detailed look back at FDA drug approvals in 2025, a year marked by regulatory turbulence, shifting policy signals, and several category-defining product launches.
Despite a dip in the total number of approvals compared to prior years, 2025 delivered meaningful innovation across oncology, rare disease, pain, infectious disease, and beyond. In this episode, Pete and Mavra break down the key approval trends at both CDER and CBER, highlight standout commercial launches, and discuss what last year’s data may signal for drug development and regulatory strategy going forward.
The conversation spans blockbuster forecasts, novel modalities, and evolving FDA expectations—from compressed review timelines to the potential phase-out of animal toxicology studies—offering listeners both a retrospective and a forward-looking view of the regulatory landscape.
Podcast topics include:
Key FDA drug approval trends from 2025 and how they compare to prior years
CDER approvals and standout launches, including Insmed’s brensocatib in non-CF bronchiectasis
Vertex’s non-opioid pain drug Journavx and the commercial realities of first-in-class pain therapies
The continued rise of antibody-drug conjugates, with a focus on Daiichi Sankyo’s TROP2 ADC
A wave of innovation in hereditary angioedema, including RNA therapies and oral acute treatments
New approvals in antibiotics, women’s health, and pulmonary fibrosis
CBER approvals, including gene therapies, vaccines, and nonprofit-led commercialization models
What a slowdown in cell and gene therapy approvals may indicate
FDA policy developments to watch in 2026, including priority vouchers, streamlined pivotal trials, and alternative preclinical requirements
A prediction (and friendly wager) on whether 2026 will surpass 2025 in total approvals
Thank you for listening. You can find previous episodes of the podcast on our website.
We’d love to hear from you—questions and feedback are always welcome.
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