Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
President Donald Trump pardoned five former NFL players, including one posthumously, for crimes ranging from perjury to drug trafficking. The pardons were announced by White House pardon czar Alice Marie Johnson.
Aethlon Medical reported Q3 2026 financial results with a $2.06 million operating loss while advancing its Australian oncology trial of the Hemopurifier device. The company achieved 27% year-to-date cost reductions and targets a late March safety review.
The FDA announced plans to restrict non-FDA-approved compounded GLP-1 drugs mass-marketed as alternatives to approved weight loss medications, citing safety concerns and misleading advertising practices.
Researchers have developed attenuated Listeria bacteria therapies that boost innate immune cells to fight cancer. Two approaches target colorectal cancer and pediatric leukemia, with FDA clearance expected soon for trials in children.
Sanofi replaced CEO Paul Hudson with Belén Garijo from Merck KGaA after a stalled turnaround. The company faces pressure to develop drugs to replace blockbuster Dupixent and navigate U.S. vaccine skepticism.
Multiple law firms have filed securities fraud class actions against uniQure N.V. after the FDA reversed its position on the company's AMT-130 Huntington's disease drug candidate, causing shares to plummet 49% in a single day.
Zydus Lifesciences resolves US patent litigation with Astellas Pharma over generic Mirabegron for $120 million plus per-unit licensing fees through September 2027, enabling continued US marketing.
A randomized trial of 210 advanced lung cancer patients found that administering checkpoint inhibitor immunotherapy in the morning nearly doubled progression-free survival and extended overall survival by nearly a year compared to later-day dosing.
