Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
Artificial intelligence is reshaping drug discovery by accelerating research timelines, reducing costs, and enabling computational analysis of biological data at unprecedented scale, marking a new scientific revolution in biotechnology.
Insilico Medicine and Memorial Sloan Kettering Cancer Center have entered a collaborative research agreement to discover new therapeutic targets for gastroesophageal malignancies using AI-powered platforms and extensive multi-omic clinical datasets.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
The U.S. orphan drug market is projected to exceed $200 billion by 2031, driven by innovation in oncology and genetic disorders. More than 1,400 FDA-designated orphan drugs are in development or marketed, with over 800 currently in clinical trials.
The global AI in biotechnology market was valued at USD 1,033 million in 2024 and is projected to reach USD 1,971 million by 2031, growing at a CAGR of 10.6%. A separate AI in precision medicine market is forecast to reach $38.88 billion by 2034 with a 35.5% CAGR.
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
Medtronic announced FDA premarket approval for Infuse bone graft in transforaminal lumbar interbody fusion procedures at one or two levels from L2-S1, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and TLIF procedures.
Compass Pathways reported COMP360 psilocybin met the primary endpoint in its second phase III trial for treatment-resistant depression, demonstrating a statistically significant reduction in depression severity. The company plans to file a New Drug Application in Q4 2025.
European regulators approved a 7.2mg "megadose" of Novo Nordisk's Wegovy involving three weekly injections. The Danish drugmaker filed suit against Hims & Hers after the telehealth company briefly launched a compounded oral semaglutide product.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
A UCLA study found that adding immunotherapy to chemotherapy before surgery is safe for borderline-resectable pancreatic cancer patients, with a subset experiencing complete tumor regression despite no overall survival advantage.
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Semaglutide and other GLP-1 receptor agonists demonstrate substantial weight loss effectiveness through appetite regulation and blood sugar control, with clinical studies showing average reductions of 14.9% to 20.9% body weight.
