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Paige AI Lymph Node Gets Breakthrough

[ Price : $8.95]

FDA grants Paige a breakthrough device designation for its Paige Lymph Node, an artificial intelligence application used to detect...

FDA Trims, Updates Biosimilars Labeling

[ Price : $8.95]

FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim trims biosimilars labeling while soliciting public comments...

Probiotics Can Hurt Hospitalized Preterm Infants: FDA

[ Price : $8.95]

FDA outlines the risks associated with off-label use of probiotics in hospitalized preterm infants to treat necrotizing enterocoli...

Positive Data on Pfizer/BioNTech Combo Vaccine

[ Price : $8.95]

Pfizer and BioNTech announce positive topline results from their Phase 1/2 study that is evaluating the safety, tolerability and i...

Olympus Recalls Insufflation Units

[ Price : $8.95]

Olympus recalls its high-flow insufflation units (model UHI-4) that are used in laparoscopic surgeries after receiving reports abo...

Breakthrough Device Changes Needed: Research

[ Price : $8.95]

Researchers from several U.S. academic medical centers suggest steps FDA and CMS could take to tighten CMS supplemental reimbursem...

Draft Guide on Remote Interactive Evaluations

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresear...

Qiagen, Myriad Partner on Cancer Diagnostics

[ Price : $8.95]

Qiagen and Myriad Genetics announce a collaboration to develop cancer companion diagnostic tests.

Consolidated OPDP Untitled Letters Page

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion launches a new Web page to display untitled letters issued for drug advertising and pr...

Add Device Identifier to Medicare Forms: Senators

[ Price : $8.95]

Sens. Grassley and Warren urge FDA to quickly voice its support for including a device identifier on Medicare claims forms.