FDA Related News

Human Drugs

FDA Misses GSK Nucala for COPD Review Decision

FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK Nucala sNDA for tre...

Marketing

Odds Low for DTC Ad Ban: Conference Speakers

Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.

FDA General

Gottlieb, McClellan Hit FDA Reorganization Plan

Former FDA commissioners Scott Gottlieb and Mark McClellan voice concerns about an HHS proposed reorganization of FDA that would centralize the review...

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.

FDA General

Inspection Disruptions Wont Rise to Covid Level: Expert

Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not rise to the level o...