FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Biologics

Byondis BLA for Breast Cancer Therapy Accepted

FDA accepts for review a Byondis BLA for SYD985 ([vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresectable locally advanced...

Medical Devices

FDA Authorizes Watmind At-Home Covid Antigen Test

FDA grants an emergency use authorization to Watmind USA for its over-the-counter at-home Covid-19 antigen test.

Federal Register

Fresenius Propoven 2% Emulsion Authorization Revoked

Federal Register notice: FDA revokes an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emulsion.

Federal Register

31 No-Longer-Marketed ANDAs Withdrawn

Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants because the products are no longer marketed.

Biologics

FDA Slow to Inspect Monkeypox Vaccine Facility: Article

A New York Magazine investigative report says FDA is partly responsible for delays in getting sufficient monkeypox vaccine doses into the U.S.

Medical Devices

Abbott Deep Brain Depression Device is Breakthrough Device

FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.

Human Drugs

Pharmacists Can Prescribe Paxlovid: FDA

FDA says state-licensed pharmacists may prescribe Paxlovid but not Lagevrio.

Medical Devices

FDA Clears VideaHealth Dental Cavity AI Algorithm

FDA gives 510(k) clearance to a VideaHealth algorithm that can help dentists identify dental caries on patient X-rays.

Human Drugs

Preemption in FDA Monograph OTC Cases Explained

Two Covington & Burley attorneys review the history of court preemption decisions involving over-the-counter drug monograph products.

Human Drugs

FDA Self-Audit Sees Continuous Manufacturing Advantages

CDER Office of Pharmaceutical Quality deputy director Mahesh Ramanadham outlines advantages found in an agency self-audit comparing regulatory actions...