FDA Related News

Human Drugs

FDA Warns CanaRx Over Unapproved Drugs

FDA issues a Warning Letter to CanaRx for causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers.

Human Drugs

Pulse Biosciences 510(k) for CellFX System

Pulse Biosciences files a 510(k) for the energy-pulse CellFX System for use in common dermatologic procedures.

Human Drugs

Adlon Therapeutics ADHD Drug Approved

FDA approves an Adlon Therapeutics 505(b)(2) NDA for Adhansia XR (methylphenidate hydrochloride) extended-release capsules for treating attention-defi...

FDA Lacks Resources for Stem Cell Regulation: Report

The Washington Post details problems with umbilical cord injections from Liveyon and FDAs inability to adequately regulate the growing stem cell indus...

Medical Devices

Alert on Robot Surgical Devices for Womens Cancer

FDA issues a safety alert on using robotically-assisted surgical devices in womens health procedures, including mastectomy and other cancer-related su...

Human Drugs

FDA OKs Janssens Tremfya One Press Injector

FDA approves a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with ...

Human Drugs

Bendeka Exclusivity Covers all Bendamustine Drugs: FDA

FDA says orphan drug exclusivity ordered by a federal court for Eagles Bendeka extends to all applications containing bendamustine, the active moiety ...

Human Drugs

CDER Office of Pharmaceutical Quality Meeting Initiatives: Report

CDERs Office of Pharmaceutical Quality says it saw record drug approval numbers in 2018.

Human Drugs

Gottlieb Updates Lawmakers on Drug Review Enhancements

FDA commissioner Scott Gottlieb outlines for U.S. House of Representative appropriators significant modernization efforts underway in CDERs Office of ...

Human Drugs

Parexel Hires FDA Oncology Center Deputy

Parexel International hires former FDA Oncology Center of Excellence deputy director Amy McKee as regulatory consulting services vice president.