An FDA advisory committee voted 7-4 that the risk of serious hypoglycemia seen with Novo Nordisk’s Awiqli insulin outweighed the convenience of its once-a-week dosing regimen for people with type…

Believing “this bill protects women across Louisiana,” Gov. Jeff Landry on Friday signed state legislation classifying the abortion-inducing drugs mifepristone and misoprostol as controlled substances. Source: Drug Industry Daily

The FDA’s draft guidance on platform technology designations for drug development outlines how sponsors can submit a designation request and the benefits of the designation. Source: Drug Industry Daily

Eli Lilly announced on Friday that it has more than doubled its investment in its Lebanon, Ind., manufacturing site with a $5.3 billion commitment that will expand its capacity to…

While Shield, Guardant’s blood-based colorectal cancer screening test, got an overall thumbs-up from an FDA advisory committee, members stressed that it’s no substitute for colonoscopy. Source: Drug Industry Daily

The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug…

Hologic BioZorb Markers with excessive adverse event reports and Vyaire Medical’s Twin Tube with the potential for the nozzle separating during patient use have been deemed as Class I recalls…

The collaborative efforts that advance the development of more generic drugs is the work of CDER’s science and research program whose 2023 annual report provides details on the efforts behind…

This week, the FDA issued a final rule reclassifying ultrasound cyclodestructive devices and published a notice seeking nominations for advisory panels of the Medical Devices Advisory Committee. Source: Drug Industry…

A federal appeals court has upheld a lower court ruling that the controversial 340B Drug Discount Program doesn’t stop drugmakers from restricting deliveries of discounted drugs to contract pharmacies. Source:…