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Novo-Nordisk
NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…
November 27, 2025

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NEWS

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Shots: Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026 Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety Additionally,…
November 26, 2025

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Kelun Biotech
NEWS

Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung05) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs Keytruda monotx. as a 1L treatment for PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥1% The trial met its 1EP of improved PFS, as concluded by IDMC & showed a favorable trend in the OS Additionally, the company…
November 25, 2025

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Arcutis Biotherapeutics
NEWS

Arcutis Biotherapeutics Reports the US FDA’s sNDA Acceptance of Zoryve (Roflumilast) to Treat Plaque Psoriasis (PsO) in Children

Shots: The US FDA has accepted the sNDA of Zoryve (0.3% roflumilast cream) for the treatment of children (2-5yrs.) with PsO (PDUFA: Jun 29, 2026) The sNDA is supported by a 4wk. MUSE study in children (2-5yrs.) with PsO & a long-term open-label study showing consistent favorable safety, tolerability, & sustained efficacy across all age…
November 18, 2025

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NEWS

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Shots: The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts Trial…
November 7, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancer sNDA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157), which showed improved PFS by 44%,…
October 7, 2025

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NEWS

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…
October 1, 2025

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NEWS

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots:                                                                                                                                                                  China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC) sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC Toripalimab is an anti-PD-1…
August 12, 2025

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