Curated news and analysis on clinical trials, drug approvals, and medical research.
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The FDA has released draft guidance to help drug developers validate New Approach Methodologies as alternatives to animal testing, establishing four validation pillars and signaling a shift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.
Gilead Sciences has agreed a global licensing deal worth up to $1.5 billion with China's Genhouse Bio for its synthetic lethal cancer candidate GH31, a MAT2A inhibitor with IND clearance in the USA and China.
The multiple myeloma treatment landscape is rapidly expanding with over 75 companies developing 80+ pipeline therapies, while clinicians navigate evolving questions about transplant timing, quadruplet regimens, and minimal residual disease testing in newly diagnosed patients.
Pulsed electric field therapy, a nonthermal ablation technique using irreversible electroporation, is being deployed for metastatic lung nodules in patients with advanced cancer resistant to standard treatments.
The FDA announced major policy changes including requiring only one study for drug approvals instead of two, and offering performance bonuses to reviewers who complete work ahead of schedule while maintaining thoroughness.
Biogen announced that litifilimab received FDA Breakthrough Therapy Designation for cutaneous lupus erythematosus and will present Phase 2 AMETHYST study results at the 2026 AAD Annual Meeting, with Phase 3 data expected in 2027.
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
The global AI in clinical trials market is expected to grow from $2.09 billion currently to $18.62 billion by 2040, driven by enhanced patient recruitment, optimized trial designs, and automation that reduces time and costs in drug development.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
U.S. Immigration and Customs Enforcement arrested multiple criminal illegal aliens convicted of serious crimes including child sex offenses, murder, sexual assault, and drug trafficking. Nearly 70% of arrests involve individuals with pending criminal charges or prior convictions in the United States.
The FDA accepted Takeda's new drug application for oveporexton, an investigational orexin 2 receptor agonist for narcolepsy type 1, and granted priority review with a PDUFA action date in Q3 2026.
