Curated news and analysis on clinical trials, drug approvals, and medical research.
BioArctic reported net revenues of SEK 184.0 M for Q4 2025, driven by Leqembi royalties and Novartis partnership income. Leqembi received multiple regulatory approvals and submissions across global markets during the quarter.
Trellus Health announced a six-month extension of its contract with Johnson & Johnson to provide the Trellus Elevate platform for inflammatory bowel disease patients, driven by strong engagement and satisfaction metrics achieved during the pilot phase.
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Twenty-one state attorneys general and 60 members of Congress filed amicus briefs supporting Louisiana's lawsuit challenging the FDA's 2023 policy that removed in-person dispensing requirements for mifepristone, enabling mail-order distribution of abortion drugs.
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
Researchers at RIKEN Center for Integrative Medical Sciences in Japan have developed a machine-learning algorithm that predicts hepatocellular carcinoma risk by analyzing the MYCN protein and tumor-promoting microenvironments in liver tissue before malignancy manifests.
Researchers have identified how the MYC protein helps pancreatic cancer evade immune detection, while a separate team discovered methods to permanently switch off cancer genes in leukemia through epigenetic therapy targeting Menin and DOT1L proteins.
The FDA has expanded a recall of raw oysters from Stellar Bay Shellfish due to norovirus contamination and issued a nationwide recall of Tippy Toes baby food fruit puree due to elevated patulin levels.
Sylvester Comprehensive Cancer Center has developed OncoPRO, a next-generation symptom monitoring program that embeds patient-reported outcomes directly into electronic medical records to detect problems earlier and strengthen patient safety in cancer care.
uniQure N.V. faces a securities fraud class action lawsuit after disclosing the FDA no longer agreed its AMT-130 data was adequate for approval, causing a 49% stock decline. Investors have until April 13, 2026 to file lead plaintiff applications.
Researchers develop machine-learned biomarker predicting liver cancer risk with 93% accuracy, while AI-driven drug repurposing offers faster, cost-effective alternatives to address cancer survivorship gaps.
59 Republican senators filed an amicus brief supporting Louisiana's lawsuit against the FDA, arguing the agency violated federal law by removing in-person dispensing requirements for mifepristone.
NovaBridge Biosciences has enrolled the first patient in a global Phase 2 study evaluating givastomig in combination with nivolumab and chemotherapy for HER2-negative, first-line metastatic gastric cancer, with top-line results expected in 2027.
American forces destroyed three boats in overnight strikes in the Eastern Pacific and Caribbean Sea, killing 11 men accused of drug smuggling. The attacks marked the first time targets on both sides of the Panama Canal were hit on the same day.
Telix Pharmaceuticals submitted a marketing authorization application in Europe for TLX101-Px, a glioma imaging agent, on February 18, 2026. The filing covers major European markets and a U.S. NDA submission will follow.
A UCLA clinical trial found that adding immunotherapy to chemotherapy before surgery is safe for borderline-resectable pancreatic cancer patients, with a subset experiencing deep, durable responses including complete tumor regression.
Arcturus Therapeutics will release fourth quarter and fiscal year 2025 financial results after market close on March 3, 2026, followed by a conference call at 4:30 p.m. Eastern Time.
The FDA has approved Harmony Biosciences' Wakix (pitolisant) for treating cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
UCLA researchers developed lipid nanoparticle-based gene editing that inserts a complete CFTR gene into human airway cells, restoring up to 100% of normal channel function in cystic fibrosis laboratory models without viral vectors.
