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

The design of the modern R&D lab may be due for a rethink.

Artificial intelligence and automation are reshaping how science gets done, yet many of the physical spaces where research happens were built around assumptions that date back decades.

In this episode of “The Top Line,” Fierce Life Sciences & Healthcare Editor-in-Chief Ayla Ellison speaks with Gensler Global Sciences Practice Area Leader Ryley Poblete about how automation, data and new research workflows are influencing lab design. As computational scientists, engineers and automated systems become more central to research teams, organizations are reconsidering how labs should be structured to support both focused work and collaboration across disciplines.

 

The design of the modern R&amp;D lab may be due for a rethink.
Artificial intelligence and automation are reshaping how science gets done, yet many of the physical spaces where research happens were built around assumptions that date back decades.
In this episode of &ldquo;The Top Line,&rdquo; Fierce Life Sciences &amp; Healthcare Editor-in-Chief Ayla Ellison speaks with Gensler Global Sciences Practice Area Leader Ryley Poblete about how automation, data and new research workflows are influencing lab design. As computational scientists, engineers and automated systems become more central to research teams, organizations are reconsidering how labs should be structured to support both focused work and collaboration across disciplines.
&nbsp;

As AI evolves, the modern R&D lab is changing

Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation.

Bodine details how physiology strengthens biotech and pharmaceutical research by clarifying how therapies behave in complex biological systems, identifying unintended effects and supporting stronger regulatory narratives. She also examines the expanding role of physiology in wearable technology, remote patient monitoring and artificial intelligence, where biological context is essential to turning large data sets into clinically meaningful insights.

The episode also highlights the society’s campaign, “Physiology: The Science Life Depends On,” aimed at elevating awareness of foundational science amid funding uncertainty. For executives, investors and health care leaders seeking sustainable innovation and patient impact, this discussion underscores a clear message: Breakthroughs depend on physiology. Listen to the full interview.

Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation.
Bodine details how physiology strengthens biotech and pharmaceutical research by clarifying how therapies behave in complex biological systems, identifying unintended effects and supporting stronger regulatory narratives. She also examines the expanding role of physiology in wearable technology, remote patient monitoring and artificial intelligence, where biological context is essential to turning large data sets into clinically meaningful insights.
The episode also highlights the society&rsquo;s campaign, &ldquo;Physiology: The Science Life Depends On,&rdquo; aimed at elevating awareness of foundational science amid funding uncertainty. For executives, investors and health care leaders seeking sustainable innovation and patient impact, this discussion underscores a clear message: Breakthroughs depend on physiology. Listen to the full interview.

From AI to wearables, physiology turns data into discovery and drives smarter drug development.

How physiology powers biotech innovation (Sponsored)

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.

In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency.

To learn more about the topics in this episode: 


FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases 


Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout 


Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial 

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.
In this week&rsquo;s episode of "The Top Line," Fierce Pharma&rsquo;s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency&rsquo;s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency&rsquo;s "case-by-case" approach, as indicated in the article, could be similar to&mdash;and different from&mdash;CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency.
To learn more about the topics in this episode:&nbsp;
<ul>
<li>
<a href="https://www.fiercebiotech.com/biotech/fda-signals-tailored-approach-carefully-shepherd-car-t-therapy-autoimmune-diseases">FDA signals tailored approach to &lsquo;carefully shepherd&rsquo; CAR-T therapy for autoimmune diseases</a>&nbsp;
</li>
</ul>
<ul>
<li>
<a href="https://www.fiercebiotech.com/biotech/kyverna-gains-clear-view-first-car-t-approval-autoimmune-disease-after-truly-remarkable-sps">Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout</a>&nbsp;
</li>
</ul>
<ul>
<li>
<a href="https://www.fiercebiotech.com/biotech/cabalettas-car-t-therapy-wipes-out-b-cells-small-autoimmune-trial-without-preconditioning">Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial</a>&nbsp;
</li>
</ul>

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

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