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After years of trying to pass legislation that would allow the U.S. government to negotiate with drugmakers on prescription drug prices for the Medicare program, the Democrat-controlled U.S. House of Representatives passed such a bill on Friday in a 220-207 vote. Read More
Bavarian Nordic is chiding the FDA after the agency recommended intradermal (ID) administration of Jynneos, the company’s monkeypox vaccine, in its Aug. 11 Emergency Use Authorization (EUA). Read More
A new FDA study of character-space-limited (CSL) communications to promote prescription drugs showed that patients understood a drug’s risk better when the risk was included in an initial tweet rather than in a link to that information located on a separate landing page. Read More
New evidence shows that an additional 135 million COVID-19 vaccine doses manufactured at the troubled Emergent BioSolutions’ Bayview, Md., facility will need to be destroyed following the discovery of quality deficiencies. Read More
An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More
Researchers in Europe used Abbott’s i-STAT TBI (traumatic brain injury) test to show how two blood-based biomarkers can effectively predict the initial outcome of such injuries. Read More