May 18, 2026

MHLW Approves Expanded Use of GSK’s Arexvy for Younger Adults at Increased RSV Risk

GSK reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded approval of its RSV vaccine, Arexvy, to include adults aged 18-49 years who are at increased risk of RSV disease. With this decision, Arexvy becomes the first RSV vaccine approved in Japan for all adults aged 60+, as well as at-risk adults aged 18-59 years. The expanded approval was supported by data from the P3b study, which demonstrated non-inferior immune responses in at-risk adults aged 18-49 years compared with adults aged ≥60 years, while maintaining a safety and reactogenicity profile consistent with earlier studies. The multi-country study enrolled 1,458 participants across 52 sites in six countries, including Japan. Vaccine efficacy had previously been established in the P3 study. The safety profile remained consistent with prior studies, with mostly mild-to-moderate and transient adverse events including injection-site pain, myalgia, fatigue, arthralgia, and headache. Additionally, Japan’s PMDA accepted prescribing information updates for immunocompromised (IC) patients based on data from the P2b study.

Source: GSK PR May 18, 2026

May 19, 2026

Leads Biolabs’ Opamtistomig Advances to Pivotal P3 Study in Advanced EP-NEC

Leads Biolabs received approval from China’s Center for Drug Evaluation (CDE) under the NMPA to initiate a pivotal P3 study of its proprietary PD-L1/4-1BB bispecific antibody Opamtistomig (LBL-024) as a 1L treatment for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The randomized, double-blind, multi-centre study, encouraging efficacy and favourable safety results from a completed P1b/I2 POC study, with detailed findings expected at the 2026 ESMO Congress. Leads Biolabs also plans to file a BLA in Q3 2026 for Opamtistomig monotherapy in 3L or later EP-NEC patients, while advancing additional P3 studies across 13 solid tumors incl. NSCLC, SCLC, biliary tract cancer, and ovarian cancer. Developed using the company’s proprietary X-Body platform, Opamtistomig is designed to simultaneously block PD-L1-mediated immune suppression and activate the 4-1BB co-stimulatory pathway, enhancing T-cell activation and anti-tumor immune response with a safety profile comparable to PD-1/PD-L1 inhibitors. The therapy has already received multiple regulatory recognitions, including BTD from China’s NMPA, ODD from the U.S. FDA and EC, and FTD from the FDA for EP-NEC.

Source: BioSpace PR May 19, 2026

May 20, 2026

China’s NMPA Approves Expanded Indications for Mabwell’s Denosumab Biosimilar MAIWEIJIAN

Mabwell reported that NMPA (China) has approved a supplemental application for MAIWEIJIAN (denosumab injection) for additional indications in bone metastases from solid tumors and multiple myeloma to delay or reduce skeletal-related events including pathological fracture, spinal cord compression, bone radiotherapy, or bone surgery. MAIWEIJIAN is a biosimilar of Xgeva approved in Mar 2024 in China for treating unresectable giant cell tumor of bone in adults and skeletally mature adolescents, and was also approved in Pakistan in Aug 2025 as the country’s first denosumab biosimilar. Denosumab is a fully human recombinant anti-RANKL mAb that blocks the RANKL/RANK/OPG signalling pathway to prevent skeletal-related events from bone metastases, offering targeted action, superior clinical efficacy in patients who failed bisphosphonate therapy, and reduced renal toxicity compared to bisphosphonates.

Source: PR Newswire PR May 20, 2026

May 21, 2026

Bayer’s Kerendia Receives FDA Priority Review for Expanded CKD Indication in Type 1 Diabetes

U.S. FDA has accepted its sNDA and granted Priority Review for Kerendia (finerenone) to treat chronic kidney disease associated with type 1 diabetes. The submission is supported by the P3 FINE-ONE study, published in the NEJM in Mar 2026 and presented at ASN Kidney Week in Nov 2025 as “Featured High-Impact Clinical Trial” which demonstrated a statistically significant 25% reduction in UACR vs placebo over 6 mos. UACR is a critical predictor of kidney and CV events, and its reduction correlates with delayed disease progression, as shown in previous type 2 diabetes P3 FIDELIO-DKD, FIGARO-DKD studies. CKD affects 30% of people with T1D, with one in four progressing to ESKD; globally, 9.5M people lived with T1D in 2025, projected to reach 13.5-17.4M by 2040. Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, is the first MR pathway drug demonstrating heart and kidney benefits across five P3 studies and is approved in over 100 countries for CKD with T2Ds and in the U.S., Japan, and EU for heart failure with LVEF ≥40%.

Source: Bayer PR May 21, 2026

May 22, 2026

AbbVie Receives Positive CHMP Opinion for MAVIRET in Acute Hepatitis C Treatment

AbbVie reported that the EMA’s CHMP has adopted a positive opinion recommending approval of MAVIRET (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA), for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged ≥3 years in the EU, with a final EC decision expected in Q3 2026. If approved, MAVIRET would be indicated for both acute and chronic HCV infection in the EU. The positive opinion is supported by data from the P3 M20-350 study, in which 8-wk MAVIRET treatment achieved a 96% SVR12 cure rate in adults with acute HCV infection, while maintaining a safety profile consistent with prior experience; the most common adverse events were fatigue, diarrhoea, headache, and asthenia. The global study enrolled 286 patients across 70 sites and evaluated once-daily oral treatment followed by a 12-wk follow-up.  AbbVie highlighted that acute HCV is often asymptomatic and undiagnosed until progression to chronic liver disease, emphasizing that earlier diagnosis and timely treatment are critical to reducing onward transmission and supporting global HCV elimination efforts, in line with global clinical guidance and the 2026 WHO Global Hepatitis Report.

Source: AbbVie PR May 22, 2026

May 28, 2026

Sanofi Receives FDA Priority Review for Venglustat in Type 3 Gaucher Disease

Sanofi reported that the U.S. FDA has accepted the NDA for venglustat and granted it Priority Review for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder associated with severe neurological complications. If approved, venglustat would become the first therapy in the U.S. specifically targeting the neurological manifestations of GD3. The NDA is supported by positive data from the P3 LEAP2MONO study, which evaluated venglustat in adult and pediatric GD3 patients with neurological symptoms who had previously achieved stabilization of systemic disease with enzyme replacement therapy (ERT). The study met both primary endpoints and three of four key secondary endpoints, while demonstrating an overall favorable safety profile with no new safety signals.

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