FDA warns Mt. Laurel, NJ-based United Health Products about serious violations in its clinical study of the CelluSTAT absorbable hemostat.
A Friends of Cancer Research online data analysis shows the FDA accelerated approval program is working as designed to speed innovative drugs to the m...
A HuffPost report says a tariff on imported drugs could lead to shortages of medications that patients need.
FDA approves GSKs Nucala (mepolizumab) as an add-on maintenance treatment for certain adults with chronic obstructive pulmonary disease.
Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.
FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medic...
Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increase...
FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a contract manufacturer of several ophthalmic surgical ...
