Researchers studying a deadly virus discovered a key protein behind its lethality and successfully used antibodies to ...

Regeneron’s gene therapy, dubbed DB-OTO, is a cell-selective AAV gene therapy for children with hearing loss stemming from a ...

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

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

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

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

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

Pfizer has teamed up with Summit Therapeutics to assess whether one of the industry’s hottest cancer candidates works well ...

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 ...

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

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