A vaccine in development would be the first proactive treatment for overdose and fentanyl addiction, if approved. A vaccine ...

The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 ...

Partner Reed Kathrein Scrutinizing Alleged Misstatements on Prostate Cancer Drug TLX591 Progress and Third-Party ManufacturingSAN FRANCISCO, Dec. 27, 2025 /PRNewswire/ -- National shareholder rights ...

The company is enhancing its end-to-end platform to accelerate therapeutic development from early research to clinical trials.

Nonprofit founder and CEO, Craig Martin, notes that the industry will likely see more alternative gene therapy ...

Nona Biosciences, a global biotechnology company advancing biotherapeutic discovery through innovative technology platforms, today announced the expansion of its integrated discovery and development ...

Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a ...

Gene Holdings Inc. , a clinical-stage, non-viral genetic medicines company, today announced its financial results for the full year ended October 31, 2025, and provided a business update. "We are ...

Samsung Biologics acquires Human Genome Sciences from GSK for $280 million, expanding its US manufacturing footprint. The ...

TLX591-CDx (Illuccix® in approved jurisdictions, 68Ga-PSMA-11): Positive data from Phase 3 study in Chinese patients provides the basis for near-term NDA submission in China.

Jessica Lin and Zhenqi (Pete) Shi from Genentech describe a novel machine learning approach to predicting retention times for ...

Abbott (NYSE: ABT) received FDA clearance for its Amplatzer Piccolo delivery system for use with the Amplatzer Piccolo ...