FDA Webview
X
about-us-banner

FDA Related News

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

FDA Approves Takedas Orzeyful for Narcolepsy Type 1

FDA approves Takedas Orzeyful as the first drug to treat all symptoms of narcolepsy type 1 in adults.

latest-news-card-1
Human Drugs

Fresenius Recalls Morphine Injection Syringe Lot Due to Labeling Mix-Up

Fresenius Kabi recalls one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a labeling mix-up that coul...

latest-news-card-1
Human Drugs

Dabur India CGMP Violations

FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.

latest-news-card-1
Medical Devices

Quality System Issues at Koven Technologies

FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.

latest-news-card-1
Human Drugs

Multiple Violations in Brunner Hygiene Unapproved New Drugs

FDA warns Germanys Thomas Brunner Hygiene about CGMP and other violations in its production of unapproved and misbranded antiperspirants.

latest-news-card-1
Human Drugs

Jazz to Remove Zepzelca Second-Line Indication

Jazz Pharma says it will seek FDA approval to remove Zepzelcas (lurbinectedin) second-line metastatic small cell lung cancer indication based on data...

latest-news-card-1
Biologics

Allergan sBLA for Botox Accepted for Review

FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance...

latest-news-card-1
Medical Devices

FDA Warns of High-Risk Issue With BD Intraosseous Needle Sets

FDA issues an early alert warning healthcare providers not to use certain Becton Dickinson intraosseous vascular access needle sets after the company ...

latest-news-card-1
Human Drugs

Liebel-Flarsheim Recalls Optiray Imaging Contrast Agent

Liebel-Flarsheim recalls one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate contamination that ...

latest-news-card-1
Human Drugs

Electronic Common Document Updated Support Package Out

The International Council for Harmonization says its electronic common technical document working group has issued updated support materials for versi...