FDA Related News

Human Drugs

FDA Approves Gileads Yeztugo for HIV Prevention

FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.

Human Drugs

GDUFA Post-Warning Letter Meeting Guidance

FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...

Open Bipartisan Probe of RFK Vaccine Plans: Pallone

House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary Robert Kennedys act...

Biologics

CBERs Prasad Named Chief Medical/Scientific Officer

CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissioner Marty Makary.

Human Drugs

Bavarian Nordic Sells Priority Voucher for $160 Million

Bavarian Nordic enters into an agreement to sell for $160 million a priority review voucher that was awarded for gaining approval of its chikungunya v...

Human Drugs

Court OKs FDA Ozempic Drug Shortage Action

A Texas federal judge rules FDA acted properly in removing Novo Nordisks Ozempic and Wegovy from its drug shortage list.

Biologics

Gottlieb Believes CBER Will Probe Sarepta Approval

Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sareptas approval of Duchenne muscular dystrophy gene therapy Elevidys based on two...

FDA General

FDA Webview Closed on Juneteenth (6/19)

FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.

Medical Devices

Multiple Violations at Reset Technology Corp.

FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental devices.

Human Drugs

Elevidys Shipping Nixed After 2nd Liver‑Failure Death

Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchen...