At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023. 

To learn more about the topics in this episode: 
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37
2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs

At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023. 
To learn more about the topics in this episode: 
<ul>
<li><a href="https://www.fiercepharma.com/special-reports/2023-drug-approvals-after-down-year-fda-signs-bounty-new-medicines" data-cke-saved-href="https://www.fiercepharma.com/special-reports/2023-drug-approvals-after-down-year-fda-signs-bounty-new-medicines">2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer</a></li>
<li><a href="https://www.fiercepharma.com/special-reports/2022-drug-approvals-after-aduhelm-fiasco-fda-endorsements-were-harder-come" data-cke-saved-href="https://www.fiercepharma.com/special-reports/2022-drug-approvals-after-aduhelm-fiasco-fda-endorsements-were-harder-come">2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37</a></li>
<li><a href="https://www.fiercepharma.com/special-report/2021-s-new-drug-approvals" data-cke-saved-href="https://www.fiercepharma.com/special-report/2021-s-new-drug-approvals">2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs</a></li>
</ul>

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
&nbsp;

A closer look at the bounty of new drug approvals in 2023

In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development. 

Although both pathways are intended to speed development, they are not interchangeable. Plant outlines the key distinctions, noting that Breakthrough Therapy requires evidence of substantial improvement over existing treatments, while RMAT is available for regenerative medicine therapies and centers on preliminary clinical evidence indicating the potential to address unmet medical needs. 

The conversation also explores the strategic choices that determine whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines. 

Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy. 

Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration. 

 

In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at&nbsp;Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development.&nbsp;
Although both pathways are intended to&nbsp;speed&nbsp;development, they are not interchangeable. Plant outlines the key distinctions, noting that Breakthrough Therapy&nbsp;requires&nbsp;evidence of substantial improvement over existing treatments, while RMAT&nbsp;is available for regenerative medicine therapies and&nbsp;centers&nbsp;on preliminary&nbsp;clinical&nbsp;evidence&nbsp;indicating&nbsp;the&nbsp;potential to address unmet medical needs.&nbsp;
The conversation also explores the strategic choices that&nbsp;determine&nbsp;whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines.&nbsp;
Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy.&nbsp;
Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration.&nbsp;
&nbsp;

FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development (Sponsored)

In this episode of “The Top Line,” recorded on site at Fierce Biotech Week in Boston, Fierce’s Ayla Ellison sits down with Christelle Huguet, Ph.D., executive vice president and head of R&D at Ipsen, to discuss how the company is building its pipeline through external innovation while maintaining internal scientific accountability.

Huguet explains Ipsen’s approach to partnering, describing the company as an “accelerator” that helps move promising science from academic labs and biotech partners toward patients. She also discusses how Ipsen evaluates which programs move forward, why transparency with partners is essential from the start and what the company is watching as it heads into a year with several key clinical and regulatory milestones.

To learn more about the topics in this episode: 
Ipsen unveils data for Botox rival that drove long-acting anti-wrinkle jab into phase 3
Ipsen scuttles liver disease candidates from $952M Albireo acquisition

This week's episode is sponsored by IQVIA Biotech.

 
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

 

In this episode of &ldquo;The Top Line,&rdquo; recorded on site at Fierce Biotech Week in Boston, Fierce&rsquo;s Ayla Ellison sits down with Christelle Huguet, Ph.D., executive vice president and head of R&amp;D at Ipsen, to discuss how the company is building its pipeline through external innovation while maintaining internal scientific accountability.
Huguet explains Ipsen&rsquo;s approach to partnering, describing the company as an &ldquo;accelerator&rdquo; that helps move promising science from academic labs and biotech partners toward patients. She also discusses how Ipsen evaluates which programs move forward, why transparency with partners is essential from the start and what the company is watching as it heads into a year with several key clinical and regulatory milestones.
To learn more about the topics in this episode:&nbsp;
<ul>
<li><a href="https://www.fiercebiotech.com/biotech/ipsen-posts-data-drove-long-acting-anti-wrinkle-jab-phase-3">Ipsen unveils data for Botox rival that drove long-acting anti-wrinkle jab into phase 3</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/ipsen-scuttles-liver-disease-candidates-952m-albireo-acquisition">Ipsen scuttles liver disease candidates from $952M Albireo acquisition</a></li>
</ul>
This week's episode is sponsored by <a href="https://www.iqviabiotech.com/">IQVIA Biotech.</a>
&nbsp; Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit <a href="https://url.us.m.mimecastprotect.com/s/1v3CCQWBXRslR28JsxfOUGfiN5?domain=iqviabiotech.com/">IQVIABiotech.com</a>
&nbsp;

Ipsen R&D chief on pipeline discipline, partnerships and 2026 milestones

Marker 01

In this sponsored episode of The Top Line, experts from Myriad Genetics join host Stephanie Butler to examine how tumor-informed molecular residual disease, or MRD, testing is beginning to redefine what early insight can mean in oncology drug development. As biomarker-driven therapies become more precise, the ability to understand response earlier and more clearly is increasingly being viewed as foundational to smarter development strategy.

The discussion looks at how ultrasensitive, tumor-informed MRD assays can help track response over time, potentially surface deeper signals earlier and inform decisions that shape trial design, patient selection and regulatory direction. It also considers why these capabilities may become more important as oncology programs face growing pressure to balance speed, flexibility and evidence generation.

Listeners will hear why early diagnostic strategy is increasingly seen as a competitive differentiator, how MRD can help teams make better decisions sooner and why its role in oncology development is expected to continue to evolve and expand.

In this sponsored episode of The Top Line, experts from Myriad Genetics join host Stephanie Butler to examine how tumor-informed molecular residual disease, or MRD, testing is beginning to redefine what early insight can mean in oncology drug development. As biomarker-driven therapies become more precise, the ability to understand response earlier and more clearly is increasingly being viewed as foundational to smarter development strategy.
The discussion looks at how ultrasensitive, tumor-informed MRD assays can help track response over time, potentially surface deeper signals earlier and inform decisions that shape trial design, patient selection and regulatory direction. It also considers why these capabilities may become more important as oncology programs face growing pressure to balance speed, flexibility and evidence generation.
Listeners will hear why early diagnostic strategy is increasingly seen as a competitive differentiator, how MRD can help teams make better decisions sooner and why its role in oncology development is expected to continue to evolve and expand.

A closer look at the bounty of new drug approvals in 2023

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