FDA warns Irvine, CA-based Nihon Kohden Digital Health Solutions that it is marketing an adulterated and misbranded unapproved medical device.
Witnesses at a House Energy and Commerce Health Subcommittee hearing urge lawmakers to modernize the nation's clinical trial system, and strengthen FD...
House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are strengthening or und...
FDA acting commissioner Kyle Diamantas positions the agencys four public health pillars as a means to fulfill its enduring mission in a new era.
A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facility manufacturing the...
A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.s efforts to eliminate childhood vaccine requirements says his aides asked FDA for access ...
FDA grants Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nep...
Neurelis petitions FDA to ensure that any generic version of diazepam nasal spray is no less safe and effective than its Valtoco for all approved uses...
