Philips issues an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which could pose a risk for...
A just-posted, four-item Form FDA-483 sheds light on medical device reporting and other violations cited in a 2022 inspection of iRhythms ZIO AT arrhy...
Eli Lilly says a head-to-head clinical trial comparing its migraine drug Emgality (galcanezumab-gnlm) to Pfizers Nurtec ODT (Rimegepant) did not meet ...
FDA approves Premia Spines TOPS System as an alternative to spinal fusion for treating certain patients with degenerative spondylolisthesis.
FDA publishes a CVM guidance entitled #171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Con...
FDA grants Genentech accelerated approval for its BLA for Columvi (glofitamab-gxbm) and its use in treating adult patients with relapsed or refractory...
FDA approves a Bristol Myers Squibb supplemental NDA to add positive data from its Phase 3 VALOR-HCM study to the U.S. prescribing information for hea...
FDA advises manufacturers that they should develop vaccines with a monovalent XBB.1.5 composition, according to a notice posted one day after an advis...
