FDA says the Risk Evaluation and Management Strategy program that has been in place since 2011 for Sanofis thyroid cancer drug Caprelsa is no longer n...
Capricor Therapeutics reaches agreement with FDA on the design and role of its HOPE-3 trial as it works to resubmit its BLA for Deramiocel and its use...
Hansa Biopharma says imlifidase met the primary endpoint in a pivotal Phase 3 study in kidney transplant patients.
FDA publishes a guide to its Electronic Submission Gateway NextGen Unified Submission Portal.
The latest University of Pennsylvania Annenberg Public Policy Center survey documents a significant drop since last fall in the percentage of people w...
FDA approves an Eli Lilly NDA for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist for treating certain adults with advan...
CBER posts 13 Form FDA-483s under the Freedom of Information Acts provision on frequently requested records.
FDA grants Biolinq a de novo authorization for its Shine system, said to be the first fully autonomous, needle-free glucose sensor.
