FDA Related News

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

Dyne Gets Breakthrough Status for Duchenne Therapy

FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystrophy that is amenable t...

FDA General

TransMedics Gets Heart Trial Conditional Approval

FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.

Medical Devices

Philips Respironics Recalls Ventilators

Philips Respironics recalls (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure ...

Human Drugs

Anixa Bio Moving Breast Cancer Vaccine Into Phase 2

Anixa Biosciences assumes full sponsorship of a Cleveland Clinic IND for ian experimental breast cancer vaccine as it heads towards a Phase 2 clinica...

Biologics

Turmoil Led to Pazdur Overriding BLA Decision: Report

A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur overriding CBER revi...

FDA General

HHS Sean Keveney Named FDA Chief Counsel

HHS acting general counsel Sean Keveney is appointed FDAs new chief counsel.