Merck and Eisai Report US FDA Approval of Welireg + Lenvima in Advanced Renal Cell Carcinoma

Shots: The US FDA has approved Welireg + Lenvima for the treatment of adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a PD-1 or PD-L1 inhibitor Approval was based on the P-III (LITESPARK-011) trial assessing Welireg (120mg, PO, QD) + Lenvima (20mg, PO, QD) vs cabozantinib in 747 pts with advanced…

ByRidhi RastogiSeptember 25, 2026

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Eli Lilly Reports the US FDA Approval for Onswik to Treat Type 2 Diabetes

Shots: The US FDA has approved Onswik (insulin efsitora alfa-gobe) along with diet and exercise to control high blood sugar in adults with type 2 diabetes Approval was based on the P-III (QWINT) trials, which evaluated Onswik (QW) in >3,400 adults with T2D; across each trial, Onswik met the 1EP, demonstrating non-inferior A1C reductions vs…

ByRidhi RastogiSeptember 25, 2026

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Astellas Reports First Patient Dosing in P-III Study of Setidegrasib in Previously Treated KRAS G12D-Mutated NSCLC

Shots: Astellas has dosed the first patient in a P-III study assessing setidegrasib vs docetaxel in ~356 pts with KRAS G12D-mutated locally advanced (unresectable) or metastatic NSCLC who progressed on or after initial Pt-based CT & checkpoint inhibitor therapy The P-III study in previously treated NSCLC builds on P-I data published in The NEJM in Mar…

ByRidhi RastogiSeptember 24, 2026

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Genentech Reports Topline P-II (CT-388-104) Trial Data on Enicepatide in T2D and Overweight or Obesity

Shots: Genentech has reported topline P-II (CT-388-104) trial data assessing enicepatide (CT-388; QW, SC) vs PBO in 447 adults living with type 2 diabetes and overweight or obesity for 48wks. Enicepatide met both 1EPs, with dose-dependent reductions in blood glucose & body weight at 48wks. At 24 mg, HbA1c fell 2.65% from 8.1% baseline, while…

ByRidhi RastogiSeptember 23, 2026

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The EC Approves AstraZeneca’s Trixeo Aerosphere for Uncontrolled Asthma

Shots: The EC has approved Trixeo Aerosphere(320/28.8/10μg) for the maintenance treatment of asthma in pts (≥12yrs.) who are not adequately controlled by a combination of a medium ICS & LABA Approval was based on the P-III (LOGOS & KALOS) trials evaluating Trixeo vs two fixed-dose dual-combination therapies of ICS & LABA: Symbicort pMDI & PT009 (in an…

ByRidhi RastogiSeptember 23, 2026

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Otsuka and Ionis Report P-III (FUSION) Trial Results for Ulefnersen in FUS-ALS

Shots: The P-III (FUSION) trial met its 1EP with ulefnersen, showing improvements in functional impairment & survival in a joint rank analysis of time to death or permanent ventilation, time to rescue, & change in ALSFRS-R from baseline to Day 505 vs PBO in pts with ALS caused by mutations in the fused in sarcoma…

ByRidhi RastogiSeptember 23, 2026

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Ionis and Roche Report Interim P-III (IMAgINATION) Trial Data on Sefaxersen in IgA Nephropathy (IgAN)

Shots: Ionis & Roche have reported interim P-III (IMAgINATION) trial results assessing sefaxersen (QM, SC) in 459 adults with IgAN for 105wks., after which eligible pts may switch to open-label treatment IMAgINATION met its 1EP, showing improvements in proteinuria reduction at 37wks., as measured by 24hr. UPCR; data to be presented in future & shared with…

ByRidhi RastogiSeptember 23, 2026

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Amgen Reports Topline P-III (OASIZ 301) Trial Data on Dazodalibep for Systemic Sjögren’s Disease

Shots: Amgen has reported topline P-III (OASIZ 301) trial results evaluating dazodalibep vs PBO in adults (n=~621) with Sjögren's disease with mod. to sev. systemic disease activity (ESSDAI ≥ 5) Trial met its 1EP, showing statistically significant & clinically meaningful improvement at Wk. 48, as measured by the ESSDAI, with benefits seen as early as…

ByRidhi RastogiSeptember 23, 2026

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Roche Reports EC Approval of Susvimo to Treat nAMD

Shots: The EC has approved Susvimo (ranibizumab 100mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal) Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to ranibizumab (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi RastogiSeptember 22, 2026

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Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Shots: J&J has reported the P-III (Study 451) trial data, assessing Caplyta (lumateperone; 42mg, QD) vs PBO for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder, at Psych Congress 2026 Trial met its 1EP, showing a 4.8-point greater reduction in YMRS total score at Wk. 3, with…

ByRidhi RastogiSeptember 22, 2026

Merck and Eisai Report US FDA Approval of Welireg + Lenvima in Advanced Renal Cell Carcinoma

Eli Lilly Reports the US FDA Approval for Onswik to Treat Type 2 Diabetes

Astellas Reports First Patient Dosing in P-III Study of Setidegrasib in Previously Treated KRAS G12D-Mutated NSCLC

Genentech Reports Topline P-II (CT-388-104) Trial Data on Enicepatide in T2D and Overweight or Obesity

The EC Approves AstraZeneca’s Trixeo Aerosphere for Uncontrolled Asthma

Otsuka and Ionis Report P-III (FUSION) Trial Results for Ulefnersen in FUS-ALS

Ionis and Roche Report Interim P-III (IMAgINATION) Trial Data on Sefaxersen in IgA Nephropathy (IgAN)

Amgen Reports Topline P-III (OASIZ 301) Trial Data on Dazodalibep for Systemic Sjögren’s Disease

Roche Reports EC Approval of Susvimo to Treat nAMD

Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

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