Moderna files a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 vaccine.
FDA makes available two International Council for Harmonization draft guidances on drug analytical procedures.
FDA removes N95 respirators from its medical device shortage list, which it says signals that demand or projected demand for this type of face protect...
FDA releases a final guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Qu...
Integra LifeSciences begins a global product removal of all CereLink intracranial pressure monitors after customer reports were received about devices...
FDA approves an Incyte supplemental NDA for Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor for treating adults with c...
FDA says the Medtronic recall of HVAD batteries for electrical faults is Class 1.
CDERs Office of Pharmaceutical Quality issues an upbeat outlook for drug quality in its FY 2021 annual report, with data on drug manufacturing sites a...
