FDA Related News

Medical Devices

FDA Clears DeepEcho AI Fetal Ultrasound

FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.

Human Drugs

Cycles Harliku Approved for Alkaptonuria

FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients with alkaptonuria.

Human Drugs

FDA Warns on Transderm Scop Heat Complications

FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-relate...

Marketing

DTC Ads Kennedys Next Target?

Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies away from DTC advertis...

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.