Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
BriaCell Therapeutics transfers exclusive license for Soluble CD80 cancer therapy to subsidiary BriaPro in deal valued at C$1.18 million, with BriaCell retaining 78% stake and providing $3 million credit facility.
Multiple Indian drugmakers begin selling generic versions of Ozempic and Wegovy following March patent expiration, with prices 50-60% below branded counterparts. The launches signal global pricing shifts as Novo Nordisk faces patent losses across multiple markets.
Multiple institutional investors expanded their positions in AstraZeneca during the third quarter, with AMG National Trust Bank, Cibc World Market Inc., and Advisors Asset Management Inc. increasing holdings by approximately 20%.
Alphamab Oncology has dosed the first patient in a Phase III study of JSKN003, a biparatopic HER2-targeting ADC, for HER2-positive advanced colorectal cancer. The drug demonstrated a 68.8% response rate in earlier trials.
Researchers demonstrate that a fully implanted brain device can detect walking states in Parkinson's patients during unsupervised daily activities, opening the door to adaptive deep brain stimulation therapies that adjust to real-world movement.
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025 and acquired Orna Therapeutics for $2.4 billion to develop circular RNA therapies for autoimmune diseases.
A 30-year-old female with stage IV gallbladder adenocarcinoma achieved complete metabolic resolution of metastases after three cycles of pembrolizumab, gemcitabine, and cisplatin, despite presenting without traditional risk factors.
Kingman Minerals Ltd. has received approval from the Arizona Department of Water Resources to drill seven exploration holes for Phase III at its Mohave Project, with drilling set to begin February 25, 2026.
Sixty Republican members of Congress filed an amicus brief supporting Louisiana's lawsuit to restore in-person dispensing requirements for mifepristone, challenging Biden-era rules allowing mail-order abortion drugs.
Multiple institutional investors modified their positions in AstraZeneca during the third quarter, with new stakes and adjustments reported in SEC filings. The company announced a dividend of $1.595 per share payable March 23rd.
Life sciences companies are integrating AI into clinical trial operations to reduce administrative burden and improve efficiency, while the biotechnology sector experiences a structural transformation driven by AI industrialization and institutional capital.
