Two stakeholders suggest changes to an FDA draft guidance on developing non-opioid analgesics for acute pain.
Myovant Sciences and Pfizer say FDA has told them that it found deficiencies in a supplemental NDA on Myfembree (relugolix 40 mg, estradiol 1 mg, and ...
FDA clears a Google 510(k) for its Fitbit and the companys new PPG (photoplethysmography) algorithm to identify atrial fibrillation.
Eli Lilly says new data on lebrikizumab show the therapy in combination with standard-of-care topical corticosteroids achieved at least 75% improvemen...
FDA places a partial clinical hold on Curis TakeAim Lymphoma study a of emavusertib in patients with B-cell malignancies.
A new Politico investigation details FDAs mishandling of food safety oversight, which may draw renewed interest from Capitol Hill in restructuring the...
FDA reminds healthcare providers that radiological computer-aided triage and notification devices for intracranial large vessel occlusion are intended...
Vanda Pharmaceuticals files a lawsuit to compel FDA to produce drug review records associated with the companys supplemental NDA for Hetlioz (tasimelt...