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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Discover the latest in pharmaceutical advancements with our September 2025 roundup. We're covering newly approved treatments like Rhapsido for chronic spontaneous urticaria, Palsonify for acromegaly, and Inluriyo for ESR1-mutated breast cancer. Learn about groundbreaking therapies, their impacts on patient care, and what these mean for healthcare professionals and patients alike.

• Rhapsido (remibrutinib) for the management of difficult chronic spontaneous urticaria in adults still experiencing symptoms despite antihistamine therapy.
• Palsonify (paltusotine) introduces a groundbreaking once-daily oral option for acromegaly, offering rapid control of growth hormone levels.
• Inluriyo (imlunestrant), a significant development for treating ESR1-mutated breast cancer in patients who have experienced disease progression after endocrine therapy.
• Forzinity (elamipretide hydrochloride) provides hope for children with Barth syndrome by improving muscle strength through mitochondrial support.
• Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a quicker subcutaneous option for pembrolizumab administration, simplifying immunotherapy for melanoma and non-small cell lung cancer patients.

Chapters

• (00:25) - Intro
• (00:51) - Rhapsido
• (01:47) - Palsonify
• (02:48) - Inluriyo
• (03:33) - Forzinity
• (04:09) - Keytruda Qlex
• (04:45) - Outro

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This month we explore groundbreaking FDA approvals including Ekterly for hereditary angioedema, Anzupgo for chronic hand eczema, and the new dosing regimen of Kisunla for Alzheimer’s. We’ll discuss the mechanisms, patient impacts, and data that drive these advancements.

• Ekterly (sebetralstat), approved as an oral on-demand treatment for hereditary angioedema (HAE) attacks in patients 12 years and older, providing symptom relief in just 1.6 hours compared to 6.7 hours with placebo.
• Anzupgo (delgocitinib), the first steroid-free topical treatment approved in the U.S. for moderate to severe chronic hand eczema in adults, working as a pan-Janus kinase inhibitor with twice-daily application to affected areas.
• Kisunla (donanemab-azbt), now available with an updated once-monthly dosing regimen for early symptomatic Alzheimer's disease, showing a 41% reduction in ARIA-E (amyloid-related imaging abnormalities with edema) at 24 weeks while targeting and removing beta-amyloid plaques in the brain.

Chapters

• (00:00) - Intro
• (00:24) - Overview
• (00:47) - Angioedema
• (01:10) - Ekterly
• (01:51) - Anzupgo
• (02:54) - Kisunla
• (03:45) - Outro

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