Target RWE presented significant findings on MASH and HCC at EASL Congress 2025, revealing that Type 2 diabetes substantially increases the risk of progression to MASH-related cirrhosis.

India's CDSCO expert committee has approved Novartis Healthcare's protocol amendment for a Phase IIIb extension study of iptacopan in patients with C3 glomerulopathy and idiopathic immune-complex-membranoproliferative glomerulonephritis.

Sanofi, Formation Bio, and OpenAI have partnered to develop Muse, an AI tool designed to expedite clinical trial recruitment and content creation.

A Phase II trial of eftilagimod alpha (efti) combined with pembrolizumab and radiotherapy demonstrates significant efficacy in neoadjuvant treatment of soft tissue sarcoma.

• PL Developments (PLD) received FDA approval for its Omeprazole Magnesium Tablet, an OTC product comparable to Prilosec® OTC, manufactured in their Miami facility. • The approval allows PLD to be the only US-based manufacturer of Omeprazole OTC, addressing a market with approximately $550 million in annual retail sales. • PLD successfully refinanced its corporate debt by exchanging $350 million in senior secured notes for $368.55 million in new notes, enhancing financial flexibility. • Commercial shipments of Omeprazole are expected to begin in early 2025, expanding PLD's portfolio of over 450 consumer healthcare products.

Kiora Pharmaceuticals received IND approval to begin a Phase 2 trial (ABACUS-2) of KIO-301 for vision restoration in retinitis pigmentosa patients.

The TRIALS program is repurposing FDA-approved drugs to expedite the introduction of therapies for ALS patients, leveraging existing safety data.

Invivyd's Pemivibart demonstrated a 64% relative risk reduction in COVID-19 infection compared to placebo during months 7-12 of the CANOPY Phase 3 trial.

NKGen Biotech's troculeucel demonstrated a reduction in key Alzheimer's disease biomarkers, including GFAP and p-tau181, suggesting potential for early intervention.

The European Medicines Agency (EMA) has recommended granting marketing authorization for Leqembi (lecanemab) to treat mild cognitive impairment and mild dementia due to Alzheimer's disease.

Dupixent (dupilumab) has been approved in the EU as the first and only medicine for children aged 1 to 11 years with eosinophilic esophagitis (EoE).

Elevation Oncology's EO-3021 demonstrated a 42.8% confirmed objective response rate (ORR) in Claudin 18.2-enriched gastric and GEJ cancer patients.

The Federal Court of Australia has dismissed Sanofi's appeal against Amgen's PCSK9 antibody patents, ordering that Amgen's Repatha patent applications proceed to grant under Australia's pre-2013 patent laws.

A post hoc analysis of the SUNSHINE and SUNRISE phase 3 trials reveals that secukinumab improves symptoms of moderate to severe hidradenitis suppurativa (HS).

Johnson & Johnson's TAR-200 showed an 83.5% complete response rate in patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Australian biotechnology company Inventia Life Science has launched the world's first clinical trial of LIGŌ, a 3D bioprinting device that delivers patients' own cells directly to wound sites without requiring skin grafts.

Experts highlight the evolving role of BTK inhibitors in CLL, FL, and MCL, emphasizing personalized treatment approaches and adverse event management.

The BRAIN-AF trial found that rivaroxaban did not reduce the risk of neurocognitive decline, stroke, or TIA in atrial fibrillation (AF) patients under 65.

The FDA has expanded the approval of Dupixent (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

The FDA has approved zolbetuximab-clzb (Vyloy) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.