Curated news and analysis on clinical trials, drug approvals, and medical research.
Avino Silver & Gold Mines Ltd. announced its 2026 outlook, projecting production of 1.0 to 1.2 million ounces of silver and modifying its mining method at La Preciosa to longhole sub-level caving for higher rates at lower cost.
Praxis Precision Medicines submitted NDAs for ulixacaltamide and relutrigine to the FDA, reported cash and investments of $926 million as of December 31, 2025, and disclosed a net loss of $303.3 million for full-year 2025.
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
Serina Therapeutics has enrolled the first patient in its Phase 1b registrational trial evaluating SER-252 in patients with advanced Parkinson's disease in Australia, with dosing expected to begin in the first quarter of 2026.
Online telehealth company Hims & Hers withdrew plans to offer a $49 compounded oral semaglutide pill after FDA Commissioner Marty Makary called such products "illegal copycats" and Novo Nordisk filed a patent infringement lawsuit.
The FDA announced it will generally require only one pivotal trial for drug approvals, ending the decades-old two-trial standard. The policy aims to reduce development costs and speed market access while maintaining focus on trial quality.
Johnson & Johnson announced plans to invest more than $1 billion in a next-generation cell therapy manufacturing facility in Montgomery County, Pennsylvania, expected to create 500 jobs when fully operational in 2031.
Korsana Biosciences launched from stealth with $175 million in funding to advance KRSA-028, a monoclonal antibody targeting amyloid beta plaques in Alzheimer's disease using a blood-brain barrier shuttle technology.
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.
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.
