Quick Notes: Drug News — Feb. 27, 2024 February 27, 2024 Drugs Columns Commercial Operations Regulatory Affairs Submissions and Approvals Quick Notes ...

Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing ...

Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple types of cancer.

U.S. District Judge Matthew Kacsmaryk, the Texas federal judge who could outlaw the abortion pill, mifepristone, said he will render a decision on the case “as soon as possible.” ...

Abbott’s MitraClip cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary mitral valve regurgitation (MR) in a five-year study at multiple U.S.

The FDA has issued Soligenix a Refusal to File letter for its HyBryte (synthetic hypericin) new drug application (NDA), deeming it not sufficiently complete for a substantive review. Soligenix said it ...

The FDA’s collaboration with the U.S. Patent Trade Office (USPTO) to bring down barriers that delay generics is off to a good start, according to FDA Commissioner Robert Califf, who points to drug ...

The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.

An independent committee of the UK’s National Institute for Health and Care Excellence (NICE) has proposed that England’s National Health System (NHS) use hybrid closed-loop systems for managing ...

Empirical Spine has submitted a premarket approval (PMA) application to the FDA for its LimiFlex Dynamic Sagittal Tether, a minimally-invasive outpatient alternative to spinal fusion which stabilizes ...

A federal court has entered a consent decree against Qualgen — an Oklahoma outsourcing facility that has had multiple, previous run-ins with the FDA — prohibiting the compounder from distributing ...

Roche Diabetes Care has lost its second appeal of the U.S. Patent Office’s (USPTO) rejection of a blood glucose electrochemical sensor as unpatentable.