FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding Project Orbis from ...
FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despite being cautioned by...
A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows significant clinica...
FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.
FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.
FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.
FDA grants Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT carcinoma in patients ...
FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTSD.
