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.
FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.
FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael Rogers, who retired ...
The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug contain false and mis...
