U.S. Senator Tammy Baldwin (D-WI) writes the four biggest drug companies marketing asthma inhalers urging them to stop unfairly blocking generics from...
Merck says its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell carcinoma saw an imp...
Philips Respironics and FDA reach an agreement on the terms of a consent decree over the companys struggles to resolve issues surrounding its troubled...
FDA issues a guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.
FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.
FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products.
A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to best oversee artific...
The International Council for Harmonization releases a guidance entitled Q14 Guideline on Analytical Procedure Development.
