FDA Related News

Medical Devices

Medical Device PFAS Appear Safe: FDA

FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.

Medical Devices

BMS Files Breyanzi Marginal Zone Lymphoma sBLA

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for...

Human Drugs

Lantheus NDA for Pylarify New Formulation

FDA accepts a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen imaging agent.

Medical Devices

Alert on Boston Scientific Defibrillation Leads

FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads that may impact shock e...

Medical Devices

FDA Early Alert on Watchman Devices

FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to preve...

Medical Devices

Quarantine Some Medline ReNewal Catheters

An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due to the possibility th...

Human Drugs

FDA Accelerated Approval for Jazz Modeyso

FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.

FDA Publishes Data Standards Program Update

FDA publishes the FY 2025 Quarter 2 update to the CBER/CDER Data Standards Program Action Plan.

Human Drugs

Clarametyx Gets Fast Track for Pulmonary Infection Drug

FDA grants Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic candidate, CMTX-101, ...

Medical Devices

Mectronic Medicale Multiple Violations

FDA warns Italys Mectronic Medicale about Quality System, Medical Device Reporting, and other violations in its illegal manufacturing and marketing of...