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.

In this DNB//Back Bay Healthcare Capital Markets podcast episode, Jim Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director and Head of Equity Capital Markets at DNB, and Vasilios Kofitsas, Partner and Managing Director of Investment Banking at Back Bay Life Science Advisors, review the performance of the healthcare markets in 2024, offering insights into what 2025 could bring. With a detailed analysis of market trends, IPO activities, and investor behaviors, they evaluate the past year's challenges and the cautious optimism prevailing in the sector as the new year unfolds. As well, there's an emphasis on the importance of European investor engagement for companies looking to list in the U.S. market.

Learn more about the DNB//Back Bay Partnership and read our disclosures here.

The topic of bispecific antibodies has been an area of interest in the pharma space for a long time now. The recent news of the notable late-stage data from Akeso and Summit’s PD-1/VEGF bispecific antibody ivonescimab to treat non-small cell lung cancer that has captured the industry writ large encouraged us to revisit the topic.

To date, there have been ten bispecific antibody approvals in oncology, seven of which are for hematological malignancies. Recently, there has been more traction in development pipelines for solid tumors. Most bispecific antibody approvals are currently or projected to be above the $1M annual revenue threshold.

Podcast topics include:

• The biologics of a bispecific antibody
• The benefits of a bispecific antibody compared to autologous therapies
• The buzz around Akeso and Summit’s PD-1 VEGF bispecific antibody asset
• The broad state of bispecifics in approved products and development pipelines
• The potential of trispecifics, bispecific conjugates and beyond