Curated news and analysis on clinical trials, drug approvals, and medical research.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
Meta-analysis of seven phase 2 trials shows metastasis-directed therapy plus standard care significantly improves progression-free survival and other endpoints in oligometastatic prostate cancer patients, with a near-significant trend toward improved overall survival.
Creative Biolabs has expanded its preclinical research capabilities with an upgraded rodent behavioral profiling platform for CNS drug discovery and enhanced circRNA and nucleic acid analysis platforms for gene therapy development.
The FDA has issued draft guidance creating a "Plausible Mechanism Framework" to accelerate approval of individualized therapies for ultra-rare diseases where traditional clinical trials are not feasible. The guidance focuses on gene editing and RNA-based treatments targeting specific genetic abnormalities.
US forces conducted three strikes on suspected drug-trafficking vessels, killing 11 people in the Caribbean and eastern Pacific. The attacks bring the total death toll to at least 159 since September.
Colorectal cancer diagnoses in people under 50 now account for nearly half of all new cases, prompting specialized treatment programs that use precision medicine and liquid biopsy technology to customize care based on individual tumor genetics.
Ten-year survival data show salvage focal therapy using heat or cold ablation is as effective as radical prostatectomy for treating localized prostate cancer recurrence after radiotherapy, with significantly fewer complications and better quality of life.
New AI-powered platforms enable same-day cancer treatment decisions and streamline clinical trial matching. University of Utah's μPharma chip predicts drug responses in under four hours, while City of Hope's HopeLLM system matches patients to trials across its national network.
Moderna reported Q4 revenues of $678 million, down 29.8% year-over-year but beating analyst expectations. The FDA reversed course and will review the company's mRNA flu vaccine application.
Deupirfenidone, a deuterated form of pirfenidone, is set to be tested in a phase 3 trial this year after successful phase 2b results. The FDA and European Commission have granted orphan drug designation to support its late-stage development.
AI-powered drugmaker Earendil Labs secured $787 million to advance biologics for autoimmune diseases and cancer, while Immunic locked in up to $400 million to fund Phase 3 trials of its multiple sclerosis therapy.
uniQure disclosed the FDA will not accept Phase I/II data alone for AMT-130 approval, causing shares to drop 49%. The company held regulatory meetings and reported $622.5 million in cash while investors face an April 13 class action deadline.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Research from Germany and Australia shows zebrafish functional testing can identify false-positive SMA newborn screening results, preventing unnecessary treatment in rare cases where infants carry functional SMN1 gene variants.
The FDA has released draft guidance to help drug developers validate New Approach Methodologies as alternatives to animal testing, establishing four validation pillars and signaling a shift toward human-centric safety data in drug development.
Novo Nordisk received FDA approval for a 7.2-mg semaglutide dose marketed as Wegovy HD for adult patients with obesity who have tolerated the standard 2.4-mg dose. The approval came through the FDA's new Commissioner's National Priority Voucher pilot program.
China became the first country to approve an invasive BCI device for commercial use, while state-backed NeuCyber Neurotech acknowledges its most advanced product lags Neuralink by approximately three years in development.
A Cleveland Clinic study of nearly 8,000 patients found minimal weight regain one year after stopping semaglutide or tirzepatide, contrasting with clinical trial results. Meanwhile, Eli Lilly's retatrutide and Roche's petrelintide continue development as next-generation obesity treatments.
Hanmi Pharmaceutical has initiated phase 2 patient dosing of belvarafenib for NRAS-mutated melanoma in Korea, enrolling the first patient at a university hospital. The multicenter trial will evaluate combination therapy in 45 patients with locally advanced or metastatic disease.
AstraZeneca announced positive Phase III trial results for Breztri Aerosphere in uncontrolled asthma patients, showing statistically significant improvements over dual-combination therapies. Deutsche Bank maintained a Sell rating with a £115 price target.
