The market opportunity lies in providing solutions and services for global medical device companies to comply with US FDA and EU MDR post-market surveillance and complaint handling requirements. This ...

Shattuck Labs (STTK) pivots from oncology to focus on SL-325 for inflammatory bowel disorders, following underwhelming ...

Preliminary BRIUMVI U.S. fourth quarter and full year 2025 net product revenue of approximately $182 million and $594 million, respectively Full Year 2026 target total global revenue of approximately ...

Allos AI today announced $5 million in seed financing led by Oxford Science Enterprises (OSE) to commercialize the industry's first "glass-box" Causal AI platform, accelerating the end-to-end ...

A new project seeking to transform the drug delivery process and take projects out of “the valley of death” between aspiration and accomplishment is getting help from La Jolla-based medical research ...

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...

Please provide your email address to receive an email when new articles are posted on . AIM-MASH AI Assist is the first AI drug development tool to be qualified by the FDA. The tool is designed to ...

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. The agency gave a green light to the AI-Based Histologic ...

Dec 3 (Reuters) - Excelsior Sciences said on Wednesday it has raised $95 million to develop technology that uses machines and artificial intelligence to accelerate the development and testing of small ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71. LONDON — In the year-plus since Najat Khan joined the AI-focused drug ...

In three draft guidance documents, the FDA has laid out pointers to help companies craft better drug development programs and drug applications. The FDA on Thursday released three guidance documents ...