Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has approved Eli Lilly's GLP-1 weight loss pill Foundayo, which will compete with Novo Nordisk's Wegovy pill. Foundayo will be available through LillyDirect and pharmacies, with prices ranging from $25 with insurance to $149-$349 for cash payers. The approval sets up a new battle in the oral GLP-1 market between the two pharmaceutical giants.
Johnson & Johnson invests over $1 billion in a new Pennsylvania cell therapy manufacturing facility for cancer and neurological diseases. The expansion addresses growing demand for advanced therapies while highlighting workforce training challenges in GMP environments. Other developments include new cell line technology for viral vector production and CRISPR-edited CAR-T manufacturing partnerships.
The World Health Organization has released INN Proposed List 134 in January 2026, disclosing non-proprietary names and structures for investigational drugs. This follows earlier lists published in July 2025 (List 133) and February 2025 (List 132), providing comprehensive data on drug candidates in development.
Medivir's 2025 Annual Report highlights FDA Orphan Drug Designation for MIV-711 in Osteogenesis Imperfecta and promising fostrox liver cancer data showing 13.7-month median survival. The company raised SEK 196 million to fund Phase 2 studies for both programs and reported year-end cash of SEK 119.2 million.
NASA is fueling the Artemis 2 Space Launch System rocket for its first crewed lunar mission since 1972, with liftoff scheduled for April 1 at 6:24 p.m. EDT. The rocket's core stage is fully fueled, while upper stage liquid oxygen loading continues, as four astronauts prepare for a 10-day voyage around the moon.
Patient-derived organoids demonstrate clinically meaningful predictive value in drug development, with validation studies showing concordance between organoid drug-response profiles and patient outcomes. These models enable earlier go/no-go decisions and more rational clinical trial design, as evidenced by their use in developing FDA Breakthrough Therapy designated candidates.
A study finds most children with enterovirus meningitis have favorable long-term outcomes, with only 8.9% experiencing adverse sequelae. Meanwhile, global data shows 259,000 meningitis deaths in 2023, with children under 5 accounting for over one-third of fatalities. Non-polio enteroviruses were the leading cause of meningitis cases worldwide.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
The FDA has granted Fast Track designation to Pasithea Therapeutics' PAS-004 for treating NF1-associated plexiform neurofibromas. The designation facilitates expedited development and review for serious conditions with unmet medical needs. Pasithea is currently conducting Phase 1/1b trials of the next-generation MEK inhibitor in patients with these tumors.
The liposomal doxorubicin market is projected to grow from $1.32 billion in 2025 to $1.77 billion by 2030, while the broader breast cancer drugs market is expected to reach $54.49 billion by 2036. Growth is driven by increasing cancer incidence, adoption of targeted therapies, and advancements in drug delivery systems including liposomal formulations and antibody-drug conjugates.
Research reveals therapy-induced senescent cancer cells and the integrated stress response pathway play dual roles in cancer immunotherapy resistance. The ATF4-LCN2 axis suppresses anti-tumor immunity by promoting immunosuppressive macrophages, while senescent cells can both enhance and inhibit immune responses. These findings highlight new targets for improving immunotherapy efficacy.
CRS3123, an investigational antibiotic for C. difficile infection, demonstrated 97% clinical cure rates and significantly lower recurrence (4% vs 23% for vancomycin) in a Phase 2 trial. The narrow-spectrum drug better preserves gut microbiome health and secondary bile acid synthesis compared to standard vancomycin treatment. These positive results support advancing CRS3123 into Phase 3 development.
A study of over 600,000 patients reveals GLP-1 drugs may reduce addiction across multiple substances, with 50% fewer substance-related deaths and significant reductions in overdoses and hospitalizations. The drugs work by dampening dopamine signaling in brain reward centers. Researchers are exploring broader applications for these medications beyond diabetes and obesity treatment.
The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.
A months-long drug investigation in North Carolina led to four arrests and over 70 felony charges, with seizures including firearms and 120 grams of cocaine and methamphetamine. Separately, a traffic stop revealed cocaine, marijuana, and a firearm, highlighting ongoing regional drug activity. Law enforcement officials note challenges from differing state marijuana laws and increasing drug-related incidents.
Express Scripts has added Milestone Pharmaceuticals' CARDAMYST nasal spray to its national formularies, improving access to the first FDA-approved self-administered treatment for PSVT in 30 years. The drug was approved in December 2025 and clinical studies show it converts PSVT episodes twice as likely and three times faster than placebo. The company has also submitted a marketing application to European regulators.
The FDA has cleared Abbisko Therapeutics' IND application for ABSK061, an oral FGFR2/3 inhibitor for achondroplasia, while BridgeBio reports positive Phase 3 results for its oral infigratinib in the same condition. Both companies are advancing oral therapies targeting FGFR3 overactivity in this genetic growth disorder.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
AI could compress drug development from 10-15 years to as little as six years, accelerating discovery and reducing late-stage trial failures. However, clinical trial execution remains heavily dependent on human oversight, with AI estimated to cut costs only 10-15% while facing regulatory and liability constraints. Major pharma companies like Gilead are investing in AI research centers despite practical limitations in trial implementation.
Recursion reported Q4 2025 financial results with $754 million in cash providing runway into early 2028. The company achieved clinical validation of its AI platform with REC-4881 showing meaningful polyp reductions in FAP patients and received its fifth Sanofi milestone payment. Full-year revenue reached $74.7 million while net loss widened to $644.8 million.
