FDA extends by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia.
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...
