Curated news and analysis on clinical trials, drug approvals, and medical research.
US forces struck three alleged drug-trafficking vessels on Monday, killing 11 people and bringing the total death toll to at least 145 since September in 42 known strikes across Latin American waters.
The European Medicines Agency recommended conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer in December 2025.
Novo Nordisk confronts rising generic threats to its semaglutide-based drugs while navigating FDA scrutiny and legal challenges. The company advances oral semaglutide into pediatric diabetes care as competitors prepare to launch imitations.
Pharmaceutical companies are deploying AI and machine learning across clinical trial execution, regulatory submissions, and drug discovery to address rising costs and lengthy timelines in drug development.
Alvotech announced successful clinical trial results for AVT80, a biosimilar to Takeda's Entyvio, meeting all primary endpoints. The company targets a $6.4 billion market opportunity with regulatory submissions planned.
UK and Brazil issue warnings about possible pancreatitis link to GLP-1 weight-loss drugs, while WADA monitors their use in Olympic athletes amid concerns about muscle loss and performance effects.
The European Commission granted conditional marketing authorization for ANKTIVA plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, marking the first approved immunotherapy for this indication in Europe.
Immatics received FDA orphan drug designation for its melanoma therapy targeting Stage II and higher cutaneous melanoma in HLA-A 02:01-positive patients, marking a regulatory milestone that brings potential market exclusivity benefits.
A newly published study in Int. J. Mol. Sci. confirms that deuterium concentration directly influences gene expression in lung adenocarcinoma cells, validating HYD LLC's three-decade research on deuterium-depleted water as a complementary cancer therapy.
Ultragenyx Pharmaceutical received an Incomplete Response Letter from the FDA for its UX111 gene therapy resubmission for Sanfilippo syndrome type A, requesting additional documentation. The company announced a 10% workforce reduction and expects profitability by 2027.
New research and precision radiation techniques aim to minimize debilitating side effects of head and neck cancer treatment, including oral mucositis, while maintaining tumor control and improving patient quality of life.
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.
Researchers from Stanford Medicine developed an injection that reprograms cells to regrow cartilage by blocking the protein 15-PGDH, offering potential treatment for osteoarthritis from aging or injury.
The FDA issued a Complete Response Letter for Disc Medicine's bitopertin application for erythropoietic protoporphyria, citing concerns over surrogate endpoints despite review under the accelerated approval pathway and Commissioner's National Priority Voucher pilot program.
The FDA declined to approve Disc Medicine's bitopertin for erythropoietic protoporphyria on February 13, 2026, citing insufficient evidence linking biomarker reductions to clinical benefit. The company will pursue traditional approval using Phase 3 APOLLO trial data expected in Q4 2026.
Longeveron Inc. appointed Stephen H. Willard as CEO effective February 11, 2026, replacing interim CEO Than Powell. The appointment comes as the company expects top-line results from its pivotal Phase 2b trial for Hypoplastic Left Heart Syndrome in Q3 2026.
Homologous recombination deficiency testing and molecular profiling are reshaping treatment strategies for advanced ovarian cancer, guiding PARP inhibitor and bevacizumab maintenance decisions in newly diagnosed patients.
The Andrew Hillman Grant for Biotech awards $1,000 to undergraduate students pursuing biotechnology careers. Applications are due June 15, 2026, with the winner announced July 15, 2026.
Nektar Therapeutics completed a $460 million public offering on February 13, 2026, selling 7.6 million shares of common stock and pre-funded warrants. The clinical-stage biotechnology company is developing immunotherapy treatments for autoimmune diseases.
Retrospective analysis of the ZUMA-2 trial found that previous ibrutinib exposure was associated with improved progression-free survival after brexucabtagene autoleucel treatment in mantle cell lymphoma patients, though with increased toxicity.
