FDA places a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152) after the World Healt...
FDAs Bioresearch Monitoring Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator and IRB inspections condu...
Four medical device stakeholders call for changes to an FDA draft guidance on notifying the agency in advance of a public health emergency about devic...
Two stakeholders suggest changes to an FDA draft guidance on developing non-opioid analgesics for acute pain.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.