The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed ...

Every day, hospitals throughout the U.S. transfuse blood or blood components, such as platelets, to save the lives of people ...

Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell and gene therapies and help ensure consistent safety and efficacy ...

and other therapies that are approved by the FDA’s Center for Biologics Evaluation and Research. Among 2024’s notable new drugs were three approvals for antibiotic therapies: Allecra ...

Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...

The cuts hit the FDA’s medical device center particularly hard, impacting product reviewers and researchers of AI-enabled ...

The ClinicalTrials.Gov Support Team expanded outreach efforts to study teams and launched a series of how-to videos to answer frequently asked questions. Northwestern Medicine’s Clinical Research Unit ...

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

announced today the opening of its cutting-edge Center of Excellence for Biologics and Cell and Gene Therapy in the heart of Research Triangle Park (RTP), North Carolina. The new facility expands ...