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Human Drugs

Catalyst Says Jacobus Patent Suit is Settled

Catalyst says it has settled its patent litigation with Jacobus over Catalysts Firdapse and Jacobus Ruzurgi.

Federal Register

Comments Extended on Drug Shortages Guide

Federal Register notice: FDA extends the comment period on a draft guidance entitled Risk Management Plans to Mitigate the Potential for Drug Shortage...

Human Drugs

Elite Supplement Center Illegally Selling SARM Products: FDA

FDA warns Elite Supplement Center that it is illegally marketing selective androgen receptor modulator products that are legally considered to be unap...

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31 No-Longer-Marketed ANDAs Withdrawn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.