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 ...
FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in young males.
Four House members introduce bipartisan legislation to legalize major provisions in President Trumps drug pricing executive order.
FDAs Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharmas NDA for mitomycin intravesical solution demonstrated a favorable...
Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.
