AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.
FDA grants Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision and slow the progress...
FDA approves a Crinetics NDA for Palsonify (paltusotine) for treating adults with acromegaly who have had an inadequate response to surgery and/or for...
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...
