FDA Related News

Medical Devices

QS, MDR Issues at Taiwans Visgeneer

FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood glucose and blood uric a...

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.

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...

Human Drugs

Two-Day Workshop on Oncology Patient Registries

FDAs Oncology Center of Excellence announces a two-day virtual public workshop to advance the development of patient registries in oncology, with a fo...

Human Drugs

CGMP Violations at Oasis Medical

FDA warns Glendora, CA-based Oasis Medical about CGMP violations in its production of finished drugs.

FDA General

Laura Loomer Targets Makary Over Prasad Exit

Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departure and mooted return...