FDA Related News

Human Drugs

FDA Accelerated Approval for Dizal Zegfrovy

FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.

Human Drugs

Staska Multiple Outsourcing Facility Violations

FDA warns Staska Pharmaceuticals, a Bennett, NE, outsourcing facility, about its multiple failures to meet requirements for such facilities.

Medical Devices

Abiomed Pump Controller Needs Update: FDA

FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in three deaths.

Human Drugs

Delayed Hereditary Angioedema Drug Wins Approval

After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating acute attacks of he...

Human Drugs

FDA Priority Review for Hunter Syndrome Therapy

FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.

FDA Inspectors Say Conditions Still Hard

A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support staff.

FDA General

FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 7.

Human Drugs

Report Highlights Study Demographic Representation

A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies last year.

Human Drugs

REMS Requirements Ended for CAR T Cell Therapies

FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the programs have burdened ...

Human Drugs

UCB Positive Data for Epileptic Encephalopathy Drug

UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for rare epileptic encephalopathy condition...