FDA approves a Pfizer NDA for Talzenna (talazoparib) with Astellas Xtandi (enzalutamide) for treating certain patients with gene-mutated metastatic ca...
The Harvard Drug Group recalls a single lot of dronabinol capsules (2.5 mg) and ziprasidone hydrochloride capsules (20 mg) after receiving a customer ...
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...
