FDA Related News

FDA General

Securing Technology, Equipment Report

The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advanced manufacturing is...

Human Drugs

Dupixent Approved for Bullous Pemphigoid

FDA has approved Sanofi and Regenerons Dupixent (dupilumab) for treating adult patients with bullous pemphigoid that mainly affects the elderly with i...

Human Drugs

Monjuvi Approved for Follicular Lymphoma

FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicu...

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...