FDA Related News

Human Drugs

2seventy bio Leukemia Trial Paused

2seventy bio says its Seattle Childrens partner has paused a Phase 1 pediatric acute myeloid leukemia trial following a patient fatality.

Human Drugs

FDA OKs Amneals Pemrydi

FDA approves an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use version of pemetrexed for injection.

Human Drugs

Starton OKd for Multiple Myeloma Trial

FDA gives Starton Therapeutics the green light to proceed with a Phase 1b clinical trial of its Star-LLD investigational continuous delivery lenalidom...

Medical Devices

NeuroOne Medical 510(k) for Ablation System

NeuroOne Medical Technologies files a 510(k) for its OneRF Ablation System.

Medical Devices

Device Software Submission Guidance

FDA publishes a guidance on recommended content of premarket submissions for software contained in medical devices.

Human Drugs

A&Z Selling Illegal New Kids Drug

FDA warns Hauppauge, NY-based A&Z Pharmaceutical about illegally marketing an unapproved childrens calcium drug.

Recorlev Web Pages False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says Xeris Web pages for Recorlev create a misleading impression about the drugs efficacy and safety.

Human Drugs

FDA Rare Disease ARC Program Update

CDER associate director for rare diseases Kerry Jo Lee highlights the one-year successes of the Accelerating Rare disease Cure program and looks to th...

Medical Devices

GE HealthCare Update on Neonatal Incubators

An FDA update says GE HealthCare has conducted preliminary testing on its newly manufactured neonatal incubators that suggests the potential for highe...

Medical Devices

OTC Erectile Dysfunction Gel Authorized in U.S.

FDA grants Futura Medical a de novo marketing authorization for over-the-counter MED3000, a topical gel formulation for treating erectile dysfunction.