FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

CDER Acting Head Corrigan-Curay Leaving in July

CDER acting director Jacqueline Corrigan-Curay decides to retire and will leave her post next month.

latest-news-card-1
Medical Devices

GE Recalls Carestation Anesthesia Devices

GE HealthCare recalls certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation in certain situations.

latest-news-card-1
Human Drugs

Bimagrumab Enhances Weight Loss: Study

New data from a Phase 2 study on Eli Lillys experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglutide) it led to prese...

latest-news-card-1
Human Drugs

Guideline on Drug Stability Testing Released

FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Products Q1.

latest-news-card-1
Human Drugs

Inspections Help Prevent Drug Shortages: Study

A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citations.

latest-news-card-1
Human Drugs

Daiichi Sankyo Drug OKd for Lung Cancer

FDA approves a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for certain adults with locally advanced or metastatic epidermal growth f...

latest-news-card-1
Human Drugs

Medline Issues Correction for Procedure Kits

Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety r...

Medical Devices

Is FDA Going After RUO Diagnostics?

Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling research-use-only (RUO) di...

latest-news-card-1
Biologics

FDA Halts Some Cell Clinical Trials

FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological material, including DNA, ...

latest-news-card-1
Biologics

Top 2 FDA Cell/Gene Therapies Officials Pushed Out

FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the latest shake-up at ...