The FDA's Office of Prescription Drug Promotion issued an untitled letter to Lundbeck over claims on its webpages for the ...
Adults between 18 and 59 who face elevated risk of severe respiratory syncytial virus infection now have a licensed vaccine ...
The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and ...
The FDA fired off warning letters to 25 telehealth companies this month for making false or misleading claims about ...
HLB’s liver cancer drug candidate ‘Rivoceranib’ has once again failed to clear the U.S. Food and Drug Administration (FDA) hurdle. The company receive ...
The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...
Lundbeck’s online promotion of migraine med Vyepti has caught the attention of the FDA, with the agency inking an untitled letter that calls out the company for potentially misleading efficacy claims.
The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...
The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor ---- FDA inspection of third-party ...
The FDA's letter to Happiest Baby cited multiple issues, including unauthorized sleep sack sizes and unsanitary refurbished Snoos.