Bimzelx (bimekizumab); Keytruda (pembrolizumab); Opdivo (nivolumab); Zilbrysq (zilucoplan); and more

New FDA Approvals

Check out our free downloads at nascentmc.com:

• Implementing AMA Style – 8 Things to Get Right in Your Next Project
• Needs Assessments – 7 Essentials for Getting Funded
• Working With Your Medical Writer – 8 Ways to Get the Most out of Them

See the full write ups for today's episode at nascentmc.com/podcast

Here are the highlights:

• BIMZELX (bimekizumab) for Moderate-to-Severe Plaque Psoriasis: The FDA approved BIMZELX for treating moderate-to-severe plaque psoriasis, making it the first psoriasis treatment targeting interleukin 17A and interleukin 17F. The approval follows data from Phase 3 trials and comes after a prior delay due to COVID-related travel restrictions.
• Neoadjuvant Pembrolizumab for NSCLC: The FDA approved pembrolizumab for neoadjuvant and post-surgical adjuvant treatment in patients with resectable non-small cell lung cancer, adding to its indications in multiple tumor types. The approval was based on the phase 3 KEYNOTE-671 trial data.
• Adjuvant Nivolumab for Stage IIB/C Melanoma: The FDA granted approval to nivolumab for adjuvant treatment of melanoma in patients aged 12 and older with resected stage IIB or IIC disease, addressing the need to reduce the risk of recurrence. This is supported by the CheckMate76K trial data.
• Zilucoplan for Myasthenia Gravis: UCB Pharma's zilucoplan, a complement C5 inhibitor, received FDA approval for treating myasthenia gravis (MG), demonstrating rapid improvements in MG-specific efficacy outcomes based on the phase 3 RAISE study.
• IDP-126 (Cabtreo) First Triple-Combination Drug for Acne: Cabtreo, a triple combination topical gel for acne, received FDA approval as the first fixed-dosed, triple-combination treatment for patients aged 12 and older with acne vulgaris.
• Penbraya Meningococcal Vaccine in Adolescents: The FDA approved Penbraya, a vaccine covering the five most common serogroups causing meningococcal disease in adolescents, based on Phase 2 and Phase 3 trial data. It's administered as a two-dose series.
• Voxzogo in Dwarfism: Vosoritide (Voxzogo) was expanded for use in children under 5 with achondroplasia, the most common form of short-limbed dwarfism, after demonstrating safety and efficacy in this age group.
• QLOSI for blurry age-related near vision: The FDA approved QLOSI, a preservative-free eye solution, for the treatment of presbyopia, improving near visual acuity by pupil modulation and increasing depth of field.
• Maxigesic IV for Post-Op Pain: Maxigesic IV, a combination of paracetamol and ibuprofen, gained FDA approval for post-operative pain management, offering faster pain relief and reduced opioid usage.
• Xphozah for Chronic Kidney Disease: Tenapanor (Xphozah) was approved as an add-on therapy for patients with chronic kidney disease who can't tolerate or respond adequately to phosphate binders, based on phase 3 trial data, addressing high blood phosphorus levels.
• Zymfentra infliximab biosimilar for ulcerative colitis and Crohn’s disease: Zymfentra, a subcutaneous infliximab biosimilar, received FDA approval for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn's disease, based on LIBERTY-UC and LIBERTY-CD study findings.

Intro and outro music

Garden Of Love by Pk jazz Collective