After hundreds of FDA employees were suddenly laid off last weekend, including dozens at the agency’s device center, the ...

After leaving the FDA, where she served as director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., ...

Entrada Therapeutics is finally able to get its Duchenne muscular dystrophy candidate (DMD) back on track after the FDA ...

OrganOx, with its system for actively preserving viable donor tissue ahead of a transplant procedure, has raised $142 million ...

Shortly after obtaining a greenlight in Europe and after more than 10 years in development, Medtronic has now received the ...

Ivonescimab remains the frontrunner, with Summit on track to report topline data from a phase 3 non-small cell lung cancer ...

As OS Therapies prepares to take its bacteria-based lung cancer therapy to the FDA for approval, the biotech has been ...

Sanofi has shared a deeper dive into its 469 million euro ($491 million) bowel disease bet, publishing phase 2 data that ...

| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...

In a recent interview with Fierce Biotech's Chris Hayden, Fortrea's Chief Technology and Data Officer Alaric Jackson ...

Celia Witten, M.D., Ph.D., is no longer deputy director of the FDA’s Center for Biologics Evaluation and Research (CBER), ...

Eleven children who were legally blind at birth all gained visual acuity after receiving MeiraGTx's investigational gene ...