This month, discover the Wegovy tablet, the first oral GLP-1 weight loss medication to be approved, Myqorzo's long-awaited treatment for obstructive hypertrophic cardiomyopathy, and several other exciting new FDA approvals. Explore these key stories and more in our December 2025 round-up.

• Wegovy (semaglutide) tablet, the first oral GLP-1 for weight loss, with significant efficacy in patient trials.
• Myqorzo (aficamten), a long-awaited and major addition to obstructive hypertrophic cardiomyopathy treatment that improves exercise capacity.
• Exdensur (depemokimab-ulaa), a new long-term, add-on treatment for severe eosinophilic asthma with twice-yearly injections.
• Jaypirca (pirtobrutinib), a non-covalent BTK inhibitor whose approval has been extended to include chronic lymphocytic leukemia and small lymphocytic lymphoma.
• Lerochol (lerodalcibep-liga), a third-generation, PCSK9 inhibitor for high cholesterol self-administered via a monthly injection.
• Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy with extended approval to include relapsed or refractory marginal zone lymphoma.

Chapters

• (00:00) - Intro
• (00:22) - Overview
• (00:34) - Wegovy
• (01:16) - Myqorzo
• (02:07) - Exdensur
• (02:56) - Jaypirca
• (03:31) - Lerochol
• (04:09) - Breyanzi
• (04:46) - Outro

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In this episode, we explore key FDA approvals from November 2025, including treatments like Keytruda Qlex for bladder cancer, Epkinly for follicular lymphoma, and the long-acting Eylea HD for macular edema. Discover what these developments mean for patients and professionals alike.

• Keytruda (pembrolizumab), approved in combination with Padcev as neoadjuvant treatment for adults with muscle-invasive bladder cancer ineligible for cisplatin-containing chemotherapy, demonstrating a 60% reduction in event-free survival events.
• Epkinly (epcoritamab-bysp) plus rituximab and lenalidomide, approved for adults with relapsed or refractory follicular lymphoma, showing a 79% reduction in disease progression risk through T-cell engagement with malignant B-cells.
• Darzalex Faspro (daratumumab and hyaluronidase-fihj), now the first and only approved treatment for patients with high-risk smoldering multiple myeloma, significantly slowing disease progression.
• Eylea HD (aflibercept ophthalmic), approved for macular edema following retinal vein occlusion with extended up to every 8-week dosing after initial treatment, maintaining visual acuity with less frequent administration.
• Caplyta (lumateperone), newly approved as an add-on therapy for adults with major depressive disorder, enhancing outcomes when used alongside existing antidepressants.

Chapters:

• (00:00) - Intro
• (00:37) - Discussion points
• (00:47) - Keytruda
• (01:20) - Epkinly
• (02:10) - Darzalex
• (02:47) - Eylea HD
• (03:14) - Caplyta
• (03:43) - Key takeaways
• (04:02) - Outro

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This month’s update dives into significant FDA approvals affecting key therapeutic areas. Discover groundbreaking treatments like Novo Nordisk’s Rybelsus for cardiovascular risk reduction in diabetes, and innovative solutions like Gazyva for lupus nephritis. Tune in to learn how these advancements could impact patient management and outcomes.

• Rybelsus (semaglutide): Exploring its new role in cardiovascular risk reduction for adults with type 2 diabetes.
• Zoryve (roflumilast): A breakthrough steroid-free topical treatment for eczema in young children.
• Gazyva (obinutuzumab): Approved for lupus nephritis, offering new hope for managing this serious kidney ailment.
• Lynkuet (elinzanetant): A hormone-free option for alleviating hot flashes due to menopause.
• Lasix ONYU (furosemide injection): Introducing an at-home infusion method for heart failure patients dealing with edema.
• Jascayd (nerandomilast): A new approval to combat the progression of idiopathic pulmonary fibrosis.

Chapters:

• (00:00) - Intro
• (00:40) - Rybelsus
• (01:36) - Zoryve Cream
• (02:17) - Gazyva
• (02:51) - Lynkuet
• (03:01) - Lasix ONYU
• (03:44) - Jascayd
• (04:16) - Outro

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