FDA warns Boston, MA-based Brigham and Womens Hospital about CGMP violations in its production of positron emission tomography drugs.
CDER launches its new Accelerate Rare disease Cures program to speed and increase the development of effective and safe treatment options for patients...
Mesa Biotech recalls its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive results due to cont...
FDA warns inhousepharmacy.vu that it is illegally marketing domperidone drug products in the U.S.
FDA says the Skippack Medical Laboratory recall of rapid Covid-19 tests that were not cleared, approved, or authorized is Class 1 and people should no...
A House committee staff report blasts Emergent Biosolutions for hiding its Covid-19 vaccine manufacturing problems from FDA and HHS.
FDA approves a new indication for Eli Lillys Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplemental oxygen, non-in...
FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distributed Covid-19 test...