FDA Related News

FDA General

FDA Preparing for Drug User Fee Negotiations

FDA prepares to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act, which expires 9/2027.

Biologics

Makary Says Novavax BLA Decision is Forthcoming

FDA commissioner Marty Makary says discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval...

Human Drugs

Paradigm Plans NDA for Rare Skin Disorder

Paradigm Therapeutics plans an NDA submission in the second half of this year for Zorblisa (SD-101), as a topical whole-body treatment for all subtype...

Medical Devices

Teal Health At-Home Pap Smear Approved

FDA approves a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer screening.

FDA Ombudsman Recommends Stakeholder Education

The FDA Office of Inspections and Investigations ombudsman program calls for establishing a dedicated Web page as a stakeholder education hub.

Medical Devices

Orchestra BioMeds Trial OKd on Sirolimus Balloon

FDA approves an Orchestra BioMed IDE to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusion Balloon for treat...

Human Drugs

Fast Track Awarded to Polycythemia Vera Drug

FDA grants Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera, a rare hematologic cancer.

FDA Implementing AI-Assisted Scientific Review

FDA commissioner Michael Makary says the agency is rolling out a generative AI-assisted scientific review tool to all Centers by 6/30.

Human Drugs

Court Confirms FDA Drug Shortage Ruling was Valid

A northern Texas judge rules in FDAs favor in a case challenging its decision last year to remove Eli Lillys weight loss and diabetes drugs Zepbound a...

Medical Devices

SS Innovations Seeks De Novo on Surgical Robot

SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.