FDA Related News

Human Drugs

Fusion Health Sold Unapproved Covid Products: FDA

FDA warns Fusion Health and Vitality that it sold unapproved, misbranded drug products intended to treat Covid-19.

Human Drugs

FDA Updates Purple Book on Biologics

FDA updates its Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated by CDER.

FDA, CDC Working on Plan to Reopen Inspections

FDA commissioner Stephen Hahn says his agency is working with the CDC on a science-driven process to restart on-site surveillance inspections when app...

FDA General

Hahn, Fauci and Redfield Quarantine After Exposure

FDA commissioner Stephen Hahn, CDC director Robert Redfield and NIH National Institute of Allergy and Infectious Diseases director Anthony Fauci quara...

Human Drugs

ICU Medical Recalls Lactated Ringers Injection

ICU Medical Recalls Lactated Ringers Injection

Human Drugs

Daiichi Sankyo, AstraZeneca Breakthrough for Enhertu

FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu for treating patients with HER2 positive unresectable or meta...

Human Drugs

Lilly Accelerated Approval for Retevmo

FDA grants Eli Lilly accelerated approval three months ahead of schedule for Retevmo (selpercatinib) for certain patients with non-small cell lung can...

Medical Devices

First Covid-19 Antigen Test Gains Authorization

FDA issues the first emergency use authorization for a Covid-19 antigen test Quidels Sofia 2 SARS Antigen FIA diagnostic test.

Medical Devices

Singlera Genomics Colon Cancer Assay Pathway

Singlera Genomics says it has completed a pre-submission meeting with CDRHs Office of In Vitro Diagnostics and it was provided clear guidance on the r...

Federal Register

FDA Withdrawing 7 ANDA Approvals

Federal Register notice: FDA announces the approval withdrawal of seven ANDAs from multiple applicants after they notified the agency that the drug pr...