Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA removed black box warnings related to breast cancer, cardiovascular disease and dementia from six hormone replacement therapies for menopausal women, following a comprehensive review of scientific literature.
Global pharmaceutical companies are accelerating licensing deals for China-developed experimental medicines, with deal values reaching unprecedented levels in 2026 as firms cut costs ahead of patent expirations.
Novartis debuted its "Relax, it's a blood test" prostate cancer awareness initiative at Super Bowl LX with an experiential booth and commercial featuring NFL tight ends, ranking seventh among all ads.
The FDA announced a new policy making one robust pivotal trial plus confirmatory evidence the default approval requirement, ending the two-trial standard. Separately, the agency finalized guidance on enhancing clinical trial participation to improve enrollment diversity.
U.S. regulators have received more than 1,400 reports since 2021 involving AI-enabled surgical devices, including allegations of botched surgeries and misidentified body parts. The FDA has authorized over 1,300 AI-integrated medical devices.
Natco Pharma has received approval from India's CDSCO to manufacture and market generic semaglutide injection, with a March 2026 launch planned. The approval comes amid patent litigation and intense competition in India's rapidly expanding diabetes and obesity drug market.
AbbVie projects 43-45% earnings growth in 2026 as newer immunology drugs Skyrizi and Rinvoq offset declining Humira sales, while maintaining its 54-year dividend increase streak as a Dividend King.
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
BridgeBio Pharma announced positive Phase 3 topline results for infigratinib in children with achondroplasia, meeting primary and key secondary endpoints. The company plans regulatory submissions in the U.S. and Europe in the second half of 2026.
The U.S. FDA granted orphan drug designation to HCB101, a next-generation immunotherapy from HanchorBio, for treating gastric cancer including HER2-positive and HER2-negative subtypes.
Research published in the New England Journal of Medicine reveals that while 43% of healthcare organizations are piloting agentic AI, only 3% have deployed it in live workflows, with 60% of executives believing it will transform patient-provider experiences.
Lundbeck's investigational anti-PACAP antibody bocunebart demonstrated statistically significant reduction in monthly migraine days versus placebo in a phase IIb trial of patients who had failed prior preventive treatments, positioning the company for phase III discussions with regulators.
Singapore unveiled a $37 billion Research, Innovation and Enterprise 2030 plan, marking a 32% increase over the previous budget. Quantum technology was identified as a strategic pillar, with the country set to host Quantinuum's most powerful quantum computer outside the U.S.
PTC Therapeutics withdrew its resubmitted new drug application for Translarna in Duchenne muscular dystrophy after the FDA indicated the data was unlikely to meet the threshold for substantial evidence of effectiveness, marking the third unsuccessful US approval attempt.
Immunic announced an oversubscribed private placement of up to $400 million to complete Phase 3 trials of vidofludimus calcium in relapsing multiple sclerosis, initiate a Phase 3 trial in primary progressive MS, and transition into a commercial organization.
The FDA will review Moderna's mRNA-1010 seasonal influenza vaccine after the company proposed a revised regulatory pathway, setting an August 2026 decision date following an earlier refusal-to-file letter.
The Virginia Supreme Court ruled that a U.S. Marine couple will keep their adopted Afghan war orphan. In the provided sources, full article text was blocked by access and server errors.
Researchers at the University of Pittsburgh School of Medicine discovered that protecting VAT macrophages in visceral fat tissue can improve insulin sensitivity, offering a potential new therapeutic approach for type 2 diabetes.
PTC Therapeutics has withdrawn its New Drug Application for Translarna (ataluren) for Duchenne muscular dystrophy after the FDA indicated the data were unlikely to meet approval thresholds, ending a pursuit spanning more than a decade.
Viking Therapeutics reported a full-year 2025 net loss of $359.64 million as it rapidly advanced its obesity candidate VK2735 into Phase 3 trials, with both injectable and oral formulations showing double-digit weight loss in earlier studies.
