The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and ...

In response, the U.S. Congress passed the Federal Food, Drug and Cosmetic Act of 1938, granting FDA with “premarket review” powers to ensure that products were safe before they were marketed to the ...

The FDA cleared marketing for the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer disease.

BioCryst has also filed its line extension application for the use of ORLADEYO oral granules in patients with HAE aged 2 to 11 years with the European Medicines Agency. Additional regulatory filings ...

Attorneys discuss ‘Loper Bright Enterprises v. Raimondo’ and its impact to medical patent cases. Many anticipated that Loper ...

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program ...

Orchestra BioMed's AVIM earns FDA breakthrough designation, sparking investor optimism. Click here to read why OBIO stock is a Hold.

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses.

If mishandled, this move could undermine public trust in the FDA and squander a once-in-a-generation opportunity to lead the ...

Up to 40% of all epilepsy diagnoses in the United States are of the drug-resistant variety, affecting 1.2 million people ...

The Trump administration is proposing a $6.8 billion budget request for the U.S. Food and Drug Administration for the 2026 ...

Optiscan and its Canadian partner have advanced in developing software that'll enable surgeons to 'talk' to remote pathologists in real time.