Curated news and analysis on clinical trials, drug approvals, and medical research.
Soleno Therapeutics provided updates on its VYKAT XR commercial launch for Prader-Willi syndrome, reporting reimbursement progress across nearly 48 Medicaid programs and over 600 prescribers, while European regulatory review continues for approximately 9,500 additional patients.
Recent reviews highlight expanding clinical benefits of GLP-1-based therapies, including antiinflammatory actions across multiple organs and cardiovascular risk reduction, with combination approaches emerging for obesity treatment.
Multiple television personalities have openly discussed their use of GLP-1 medications for weight loss, with some experiencing facial changes known as "Ozempic face" characterized by volume loss and more pronounced features.
The FDA approved KEYTRUDA and its subcutaneous QLEX formulation for platinum-resistant ovarian cancer, marking the first PD-1 inhibitor cleared for this patient population based on Phase 3 results.
With semaglutide and tirzepatide shortages resolved, the FDA is cracking down on compounded GLP-1 medications. Concerns emerge over 33 unique compounded formulations with limited safety data and nonstandard delivery methods.
MannKind Corporation has enrolled the first pediatric patient in its INHALE-1ST trial evaluating Afrezza inhaled insulin in children with type 1 diabetes. The FDA is reviewing a supplemental Biologics License Application with a decision expected by May 29, 2026.
Zydus Lifesciences Limited received final FDA approval for Ammonium Lactate Cream, 12%, a generic of Lac-Hydrin Cream. The topical prescription medication treats xerosis and ichthyosis vulgaris, with annual U.S. sales of $15 million.
Oncolytics Biotech announced FDA Fast Track Designation for pelareorep combined with bevacizumab and FOLFIRI for second-line treatment of KRAS-mutant metastatic colorectal cancer, driving shares up 19.7%.
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025, with successful phase 3 trials for cancer drug Jaypirca, next-gen obesity medicine retatrutide, and oral GLP-1 orforglipron, while Alzheimer's drug Kisunla showed cognitive decline benefits.
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
Researchers at Texas A&M University have developed a tissue-adhesive biosensor that detects inflammation biomarkers in the mouth with molecular precision, potentially shifting oral healthcare from reactive to proactive.
The FDA agreed to review Moderna's mRNA flu vaccine application after initially rejecting it, reversing course within a week. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and above, with a decision expected by August 5.
A securities fraud class action lawsuit has been filed against uniQure N.V. alleging material misstatements about its Huntington's disease gene therapy AMT-130 and FDA approval pathway between September and October 2025.
Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics and two additional collaborations totaling over $1 billion to develop treatments for immune disorders, cancer, and hearing loss gene therapies.
Vaxcyte has initiated its Phase 3 adult program for VAX-31, a 31-valent pneumococcal conjugate vaccine, with the pivotal OPUS-1 trial enrolling 4,000 adults aged 50 and older. The company plans to submit a Biologics License Application by the end of next year.
The FDA will consider revoking safety exemptions for ultra-processed foods including corn syrup, while retatrutide, a triple-receptor weight loss drug, advances through phase three clinical trials without yet receiving regulatory approval.
Nuvalent provided updates on regulatory milestones for its lead oncology programs, including FDA acceptance of the zidesamtinib NDA with a September PDUFA date and plans to submit an NVL-655 NDA in the first half of 2026.
Amazon's Ring has ended its planned partnership with police surveillance tech company Flock Safety following backlash over a Super Bowl ad, though the integration never launched and no customer videos were shared.
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
