FDA Related News

Human Drugs

FDA Fast Track for Volastra Ovarian Cancer Drug

FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer

Medical Devices

Lab Groups Seek Summary Judgment in LDT Suit

Two trade associations that oppose FDA regulation of laboratory-developed tests ask a Texas federal court to grant summary judgment in their favor in ...

Biologics

Stem Cell Company CEO Gets 36 Months in Jail

The Justice Department says Liveyon founder and CEO John Kosolcharoen has been sentenced to 36 months in prison after pleading guilty to one count of ...

Medical Devices

Fresenius Recalls Ivenix Infusion Pump Software

Fresenius Kabi recalls (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software and cybersecurity vu...

Federal Register

Panel to Review Andexxa sBLA

Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an AstraZeneca supplemental ...

Federal Register

Lexicon Diabetes Drug Heads to Panel

Federal Register notice: FDA announces that a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting will review a Lexicon Pharmaceutical...

Trial Electronic Systems, Records, Signatures Guide

FDA publishes a guidance with questions and answers on using electronic systems, records, and signatures in clinical investigations involving regulate...

Human Drugs

13 Observations in ProRx FDA-483

FDA releases the form FDA-483 with 13 observations from an inspection at the Exton, PA-based ProRx drug outsourcing facility.

Biologics

Fresenius/Formycon Stelara Biosimilar Approved

FDA approves Fresenius Kabi and Formycons biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnsons referenced Stelara.

Cassidy Wants Info on Orange Book Listing Requirements

Sen Bill Cassidy asks FDA to respond to questions about its decades-long failure to give Orange Book patent listing clarity to drug/device combination...