Curated news and analysis on clinical trials, drug approvals, and medical research.
A recent usability study examined Epic's Genomic-Indicators, a clinical decision support tool designed to integrate pharmacogenomic data into electronic health records for personalized patient care.
The Pathways clinical trial into puberty blockers has been paused after the MHRA raised concerns about minimum age limits and unquantified long-term biological risks, with recruitment now suspended pending resolution.
Bristol Myers Squibb faces a steep patent cliff with key drugs losing protection between 2027-2029, but newer products like Cobenfy show promise. The stock trades at less than 10 times earnings with a 4.2% dividend yield.
Patients with p53 aberrant or 17p deleted chronic lymphocytic leukemia face a more aggressive disease course requiring specialized treatment approaches including clinical trial enrollment and referral to high-volume centers.
The Kentucky Office of Homeland Security has issued a warning after detecting Cychlorphine, a synthetic drug ten times stronger than fentanyl, in central Kentucky. The drug is contributing to overdose deaths in neighboring regions including East Tennessee.
A measles exposure occurred on February 18 at Nemours Children's Hospital emergency department in Delaware. State health officials are conducting contact tracing and urging unvaccinated exposed individuals to receive MMR vaccine within 72 hours.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
Eighty-six countries including the US and China signed a declaration calling for secure and trustworthy AI at the five-day AI Impact Summit in New Delhi, though the statement included no concrete regulatory commitments and drew criticism for being too generic.
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
Abivax announced novel preclinical and clinical data for obefazimod at ECCO 2026, highlighting anti-fibrotic potential in Crohn's disease, favorable safety profile, and rapid onset of symptomatic relief in inflammatory bowel disease patients.
U.S. military strikes alleged drug trafficking boat in Eastern Pacific, killing three people. The attack brings total deaths from Trump administration boat strikes to 148 since September.
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
Researchers at DZNE and the University of Tübingen have identified neurofilament light chain (NfL) as a blood biomarker detectable across animal species, with levels increasing with age and predicting lifespan in mice.
Prothena reported Q4 2025 adjusted loss of 45 cents per share, meeting estimates, while ending the year with $308.4 million in cash. Roche and Novo Nordisk advanced partnered programs prasinezumab and coramitug into Phase III trials.
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
The FDA has accepted Teva Pharmaceuticals' New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine injection for treating schizophrenia in adults, based on Phase 3 trial data showing efficacy consistent with existing formulations without requiring post-injection monitoring.
The controversy over direct-to-consumer prescription drug advertising has gained renewed attention from the Trump administration and legislators, with spending reaching $9 billion in 2024 and debate centering on whether such ads benefit or harm consumers.
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
