FDA says it will reject all data coming from biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environment Technology Institu...
FDA warns Mt. Laurel, NJ-based United Health Products about serious violations in its clinical study of the CelluSTAT absorbable hemostat.
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.
Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.
