In a potentially practice-changing development for oncology, Merck announced that its Phase 3 KEYNOTE-B15 trial (also known as EV-304) has met its primary and key [Read More…]
Novo Nordisk has officially submitted a New Drug Application to the FDA for CagriSema, a first-of-its-class once-weekly injection for chronic weight management. Combining semaglutide with a novel amylin analogue, clinical data from the REDEFINE program shows the treatment can achieve over 20% weight loss in adults with obesity.
Johnson & Johnson MedTech has secured FDA approval for an expanded indication of the TRUFILL n-BCA Liquid Embolic System. This new approval allows for the treatment of chronic subdural hematoma (cSDH) via middle meningeal artery (MMA) embolization, offering a minimally invasive solution to significantly reduce the high recurrence rates associated with traditional surgery.
The U.S. FDA has approved GSK’s Exdensur (depemokimab), a revolutionary ultra-long-acting biologic for severe eosinophilic asthma. As the first treatment of its kind to require only two doses per year, Exdensur promises to improve patient adherence and significantly reduce the frequency of life-threatening asthma attacks.
Gilead has announced positive Phase 3 results for its investigational single-tablet regimen (STR) of bictegravir and lenacapavir (BIC/LEN) in the ARTISTRY-2 trial. The new combination met its primary endpoint, demonstrating non-inferiority to BIKTARVY in maintaining viral suppression in adults with HIV-1. This novel two-drug regimen combines the potent integrase inhibitor bictegravir with the first-in-class capsid inhibitor lenacapavir, representing a potential new, simplified treatment option for long-term HIV management.
Sanofi anticipates that the US regulatory decision for its investigational drug, tolebrutinib, for non-relapsing secondary progressive multiple sclerosis (nrSPMS) will be delayed beyond the previous December 2025 target action date, with further guidance expected by the end of Q1 2026.
A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.
The FDA has approved Amgen’s UPLIZNA for adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. UPLIZNA is the first and only CD19-targeted B-cell therapy approved for this indication, offering a convenient dosing schedule of just two maintenance doses per year following the initial loading regimen. The approval is based on strong efficacy data from the Phase 3 MINT trial.
Eli Lilly and Company announced groundbreaking positive topline results from the Phase 3 TRIUMPH-4 clinical trial, confirming its investigational triple-agonist drug, retatrutide, delivered unprecedented weight loss of up to 28.7% (71.2 lbs) and substantial relief from the pain and functional limitations associated with knee osteoarthritis.
GSK’s B7-H3-targeted antibody-drug conjugate, Risvutatug Rezetecan, has been granted Orphan Drug Designation by the US FDA for small-cell lung cancer (SCLC), based on promising early clinical data.
