Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
Northwestern University researchers found that levetiracetam, an FDA-approved anti-seizure medication, prevents formation of toxic amyloid-beta 42 peptides in the brain, offering a potential strategy for early Alzheimer's prevention.
The U.S. Department of Health and Human Services formally scrapped its 2025 340B Rebate Model Pilot Program following federal court rulings and issued a new Request for Information on February 13, 2026, seeking stakeholder input on the future of 340B drug pricing.
Krystal Biotech posted Q4 2025 net revenue of $107.1 million from Vyjuvek sales, with full-year revenue reaching $389.1 million. The company expanded to over 90 patients across Germany, France, and Japan while advancing its pipeline with new FDA designations.
Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm (dibutepinephrine) sublingual film, citing deficiencies in human factors validation and packaging. The company plans to resubmit as early as Q3 2026.
A class action lawsuit was filed against REGENXBIO covering the period from February 9, 2022 to January 27, 2026, following FDA clinical holds on gene therapies RGX-111 and RGX-121 after a CNS tumor was discovered in a trial participant.
A study of 366 patients found ide-cel CAR-T cell therapy achieved 81.6% overall response rate in patients 70 or older with relapsed/refractory multiple myeloma, with median progression-free survival of 18.9 months versus 5.7 months with standard regimens.
Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.
Metabolic pathway scores consistently distinguished patients who developed severe neurologic events after CAR T-cell therapy across six clinical trials, surpassing traditional inflammatory markers in predictive performance.
Researchers have developed an inhalable nanoparticle system for delivering rifampin directly to the lungs, potentially reducing tuberculosis treatment from daily to once-weekly dosing while lowering side effects and improving drug effectiveness.
The FDA has released draft guidance to help drug developers validate new approach methodologies as alternatives to animal testing, marking a milestone in the agency's roadmap to reduce reliance on animal studies in drug development.
