FDA Related News

FDA General

FDA Urged to Expand Real-World Data Use

A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of ...

Human Drugs

FDA Oxylanthanum Carbonate Complete Response Letter

FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites issues with a manufac...

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.

Human Drugs

Priority Review for Mercks Winrevair

FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.

Biologics

Vaccine Regulation Now a Political Process: Gottlieb

Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...