1. Swissmedic approves Novartis’ Coartem® Baby as the first malaria treatment for newborns: On Jul 08, 2025, Novartis announced Swissmedic, a regulatory body in Swizerland has firstly approved Coartem® (artemether-lumefantrine) Baby as the first malaria medicine for newborns and young infants. Before this approval, there was no malaria treatment for patients who weighed less than 4.5 kg. The approval is based on the Phase II/III CALINA study, which investigated a new ratio and dose of Coartem® (artemether-lumefantrine) to account for metabolic differences in babies under 5 kg.
Link: https://www.novartis.com/news/media-releases/novartis-receives-approval-first-malaria-medicine-newborn-babies-and-young-infants
2. J&J files sNDA for CAPLYTA® to prevent schizophrenia relapse: On Jul 08, 2025, Johnson & Johnson announced a new supplemental New Drug Application (sNDA) to the U.S. FDA based on the long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. Lumateperone simultaneously modulates the dopaminergic, serotonergic, and glutamatergic neurotransmissions. However, the exact mechanism remains unknown. The positive Phase 3 results support this submission. The primary endpoint showed that patients receiving CAPLYTA® for 26-week showed significantly longer time to relapse compared to the placebo arm. CAPLYTA® treatment also reduced the risk of relapse by 63% compared to the placebo.
Link: https://www.jnj.com/media-center/press-releases/supplemental-new-drug-application-submitted-to-u-s-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo
3. FDA approves updated titration schedule for Kisunla in early Alzheimer's to reduce side effects: On Jul 09, 2025, Eli Lilly and Company announced that the U.S. FDA approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt). Kisunla is a once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD) with amyloid accumulation. The approval was supported by the TRAILBLAZER-ALZ 6 study, where amyloid-related imaging abnormalities with edema/effusion were reduced by 41% at 24 weeks and by 35% at 52 weeks versus the original dosing schedule. Moreover, patients receiving the modified titration experienced a similar level of reduction in amyloid plaque and P-tau217 compared to patients receiving the original dosing regimen.
Link: https://investor.lilly.com/news-releases/news-release-details/fda-approves-updated-label-lillys-kisunla-donanemab-azbt-new
4. UK approves Lynkuet for menopause-related vasomotor symptoms: On Jul 10, 2025, Bayer announced that MHRA, the regulatory authority in the UK has approved Lynkuet™ (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elinzanetant exerts antagonistic effects on neurokinin-1 and neurokinin-3 receptors simultaneously. The approval in the UK was based on the the OASIS-1, -2 and -3 Phase III results. In OASIS-1 and -2, elinzanetant significantly reduced the mean frequency and severity of moderate to severe VMS associated with menopause compared to placebo at weeks 4 and 12. The efficacy was also maintained with over 80% of participants in the elinzanetant group achieving at least a 50% reduction in VMS frequency by week 26.
Link: https://www.bayer.com/media/en-us/bayer-receives-first-approval-worldwide-for-lynkuet-elinzanetant-in-the-uk-as-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/
5. EC approves TEVIMBRA plus chemotherapy for first-line treatment of metastatic nasopharyngeal carcinoma: On Jul 10, 2025, BeOne announced that the EC has approved TEVIMBRA® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC). NPC is a rare cancer where tumors form in the upper part of the throat, located behind the nose. The approval is based on the results of the RATIONALE-309 study. The primary endpoint showed that TEVIMBRA significantly prolonged progression-free survival in the intent-to-treat (ITT) population with a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm.
Link: https://ir.beonemedicines.com/news/european-commission-approves-tevimbrar-in-combination-with-chemotherapy-as-a-first-line-treatment-for-nasopharyngeal-carcinoma/3ed59f18-6818-4ab5-8c33-3ce2b78144df
6. FDA approves EKTERLY® for rapid relief of hereditary angioedema attacks: On Jul 7, 2025, the U.S. FDA has approved EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Angioedema is a medical condition characterized by rapid swelling of the deeper layers of the skin and mucous membranes. The approval was based on the phase III KONFIDENT clinical trial. Results showed that EKTERLY® start to exert effects with a median of 10 minutes and relieves symptoms with a median of 1.3 hours among attacks, including the larynx and the abdomen.
Link: https://ir.kalvista.com/news-releases/news-release-details/kalvista-pharmaceuticals-announces-fda-approval-ekterlyr
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