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Novartis
NEWS

Novartis Reports Topline P-III (RemIND) Trial Results on Remibrutinib in Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial met its 1EP for the three prevalent subtypes of CIndU, incl. symptomatic dermographism, cold urticaria, & cholinergic urticaria, delivering significantly higher complete response rates at Wk. 12 Additionally, Novartis has submitted…
February 18, 2026

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Akesobio
NEWS

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Shots: The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS) sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…
January 20, 2026

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J&J
NEWS

Johnson & Johnson Highlights Clinical Data on Caplyta (Lumateperone) for Major Depressive Disorder (MDD) at ACNP 2026

Shots: Data from the OLE 503 study of Caplyta & pooled results from P-III (Studies 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant, in adults with MDD presented at ANCP’26 Pooled data showed higher remission (MADRS ≤10) with treatment at 6wks. (25.5% vs 13.6%), with complete remission (MADRS ≤5) in 10.6%…
January 19, 2026

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NEWS

Emergent BioSolutions Receives US FDA Approval of sNDA for NARCAN Nasal Spray with New Carrying Case to Reverse Opioid Overdoses

Shots: The US FDA has approved Emergent BioSolutions’ supplemental NDA (sNDA) for over-the-counter (OTC) NARCAN Nasal Spray to be packaged in a new, compact carrying case designed to improve portability and everyday preparedness The new carrying case includes two blister-packed doses with a Quick Start Guide and is intended to increase accessibility, discretion, and likelihood…
January 15, 2026

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J&J
NEWS

Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved J&J's Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC Trial met its…
December 15, 2025

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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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