Curated news and analysis on clinical trials, drug approvals, and medical research.
Scientists in China report reversing Type 2 diabetes in a patient using stem cell therapy, while a separate study finds metformin may help women with diabetes live past 90. Both findings require larger trials.
DNA methylation-derived Protein EpiScores significantly improved prognostic accuracy for colorectal cancer survival when added to traditional clinical risk factors, raising concordance indices from 0.64 to 0.70 for disease-free survival and 0.70 to 0.75 for overall survival.
New data from LIBERTY studies show subcutaneous infliximab effectively restored and maintained disease control in Crohn's disease and ulcerative colitis patients after drug holiday of 16 weeks or more, with sustained efficacy through Week 102.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
Tozaro, a Bedfordshire-based biotech company, has raised £6 million in funding led by Mercia Ventures to advance its Smart Polymer technology aimed at reducing the high production costs of cell and gene therapies.
Nicox SA received positive written feedback from a pre-NDA meeting with the FDA for NCX 470, a nitric oxide-donating bimatoprost eye drop for glaucoma. The NDA submission remains on track for summer 2026.
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
Scientists at UC San Diego have identified N4BP2 as the enzyme responsible for chromothripsis, a chaotic chromosome-shattering event seen in about one in four cancers that enables rapid tumor evolution and treatment resistance.
Natco Pharma received CDSCO approval to manufacture and launch generic semaglutide injection in India next month for type 2 diabetes treatment, sending shares up over 11% on Monday.
CStone Pharmaceuticals received FDA IND clearance to initiate a Phase II trial of CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors across nine cancer indications.
Blood-based biomarkers including brain-derived tau and amyloid-beta are enabling earlier Alzheimer's disease diagnosis through non-invasive testing, though confirmatory imaging remains necessary before treatment initiation.
Shanghai Henlius Biotech received U.S. FDA approval to begin phase 1 trials of HLX15-SC, a subcutaneous biosimilar of daratumumab, for multiple myeloma treatment with significant commercial potential.
Novartis has agreed to acquire Avidity Biosciences in the first half of 2026, obtaining its RNA therapeutics platform and neuromuscular disease pipeline. Avidity's cardiovascular RNA programs will be separated into a new independent company called Atrium.
The FDA reversed its initial refusal and will now review Moderna's mRNA-based flu vaccine application, seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision targeted for August 5, 2026.
Health and Human Services Secretary Robert F. Kennedy Jr. announced the FDA will act on a petition to revoke GRAS status for dozens of processed sweeteners and starches, including corn syrup, unless companies prove they are safe.
WHOOP has partnered with Unilabs to launch its Advanced Labs programme in the UAE, offering members access to a 65-biomarker blood testing panel at Dhs733, with results integrated into the WHOOP app alongside wearable health data.
HHS Secretary Robert F. Kennedy Jr. announced the FDA will consider a petition to revoke GRAS status for dozens of processed sweeteners and starches, though he stopped short of promising new regulations on ultraprocessed foods.
