Curated news and analysis on clinical trials, drug approvals, and medical research.
A single blood test measuring p-tau217 protein can predict when cognitively unimpaired individuals will develop Alzheimer's symptoms, with a margin of error of 3-4 years, potentially accelerating clinical trials.
HEALWELL AI and WELL Health have launched WELLTRUST, a consent-first platform that uses AI to identify and recruit patients for clinical trials across WELL's network of 240+ clinics and 43,000 healthcare providers in the US and Canada.
Faron Pharmaceuticals announces Phase II BEAM-X trial evaluating bexmarilimab plus azacitidine in MRD-positive AML patients after stem cell transplantation. The Nordic AML Group-led trial will enroll 24 patients with first results expected 12-15 months after enrollment begins in Q3 2026.
Zenyaku Kogyo obtained Japanese regulatory approval for Rituxan (rituximab) as a treatment for autoimmune hemolytic anemia, a government-designated intractable disease. The approval follows a public knowledge-based application submitted in August 2025.
A comprehensive market report reveals over 180 companies are developing more than 200 PD-1 and PD-L1 inhibitor drugs, with recent fast-track designations and successful Phase III trial results driving expansion in cancer immunotherapy.
New York State Police narcotics investigator Michael O'Flaherty pleaded guilty to making false statements after tipping off a fentanyl trafficker about an active investigation and lying to federal authorities.
Phase 3 LATITUDE trial shows monthly cabotegravir-rilpivirine injections cut regimen failure risk by 18.4 percentage points compared to daily oral ART in HIV patients with documented adherence difficulties.
The U.S. Food and Drug Administration issued two Emergency Use Authorizations on February 18, 2026, for NexGard products to treat New World screwworm infestations in dogs and cats.
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-1010 seasonal influenza vaccine application, setting an August 5, 2026 review deadline after the company proposed a revised regulatory approach based on age groups.
Researchers at Washington University in St. Louis have adapted CAR-T immunotherapy to target aggregated amyloid-beta in mice, with transient CAR expression clearing brain plaques. The approach uses CD4+ T cells engineered with receptors based on lecanemab antibody sequences.
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
Phase 1/2 MARINA trial results published in NEJM show del-desiran achieved approximately 40% reduction in toxic DMPK mRNA in muscle tissue and improvements in myotonia and functional measures in myotonic dystrophy type 1 patients, with acceptable safety profile.
National Institutes of Health Director Jay Bhattacharya will serve as acting director of the Centers for Disease Control and Prevention following Jim O'Neill's departure. Bhattacharya will oversee both agencies simultaneously as the CDC faces significant instability.
RCL Homestead Bay Limited received fast-track approval to construct 2,800 residential homes and a commercial retail precinct in Queenstown. The project is estimated to contribute $720.3 million to GDP and support around 4,420 jobs during construction.
Pivya (pivmecillinam) is now available in the US for treating uncomplicated urinary tract infections in adult female patients, based on three phase 3 trials showing efficacy against susceptible bacterial isolates.
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
A randomized trial found that men with prostate cancer treated with the GnRH agonist leuprolide experienced significantly more coronary artery plaque progression than those receiving the GnRH antagonist relugolix, suggesting a biological mechanism for cardiovascular risk differences between ADT drug pathways.
