Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
Researchers at The University of Texas MD Anderson Cancer Center developed a computational approach using tumor-specific total mRNA expression (TmS) that outperformed current methods for predicting chemotherapy response in triple-negative breast cancer patients.
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.
Two financial services firms raised their price targets for Moderna in mid-February 2026, with RBC Capital increasing its target to $30 and Evercore ISI Group raising its target to $35, both maintaining neutral ratings.
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Novo Nordisk secured FDA approval for oral Wegovy tablets in December 2025 and subsequently sued telehealth company Hims & Hers for patent infringement over compounded versions. The company is the only manufacturer with an FDA-approved GLP-1 weight loss pill.
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
Sana Biotechnology appointed Brian Piper as Executive Vice President and Chief Financial Officer on February 17, 2026. Piper brings over 25 years of biopharmaceutical financial expertise to the cell and gene therapy company.
