BioPharma Dive1h
FDA, facing pressure, to review position on Zepbound, Mounjaro shortage
The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in ...
Becker's Hospital Review2h
FDA to reconsider decision barring sale of compounded Mounjaro: 5 things to know
The reconsideration follows an Oct. 11 lawsuit that prompted U.S. District Judge Mark Pittman to temporarily halt legal proceedings to give the FDA time to reassess its ruling.
FierceBiotech3h
CMR Surgical lands FDA clearance for Versius robot amid CEO swap
CMR Surgical obtained a de novo clearance from the FDA for its Versius surgical system, finally allowing its modular, ...
FDA gets drugs out faster, but some work only ‘marginally’ better and are more expensive
Dr. Steven-Huy Han, a UCLA liver specialist, has prescribed Ocaliva to a handful of patients, although he’s not sure it helps ...
Some doctors say the FDA's new notification rule about dense breasts is misleading
Women 40 and older in every state are now receiving notifications about their breast density along with their standard ...
FDA authorizes over-the-counter combined COVID-19 and flu home test
Healgen Scientific's combined COVID-19 and flu test gives people a new way to check what's causing their symptoms, FDA says.
US FDA approves Pfizer's drug for rare bleeding disorder
The U.S. Food and Drug Administration approved Pfizer's once-a-week injection for the two main types of a rare bleeding ...
FDA says egg recall over salmonella can have 'serious' health effects: Avoid these brands
Eggs sold in three states have been recalled due to possible salmonella contamination. Here's what consumers need to know ...
Food Safety News14h
FDA cracks down on food importers for major safety violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...