FDA Related News

Human Drugs

FDA Compounding Drug Updated Guidance

FDA issues policy clarifications for drug compounders during the Covid-19 pandemic.

Human Drugs

Manufacturing, Supply Chain Q&A

FDA posts a question-and-answer document on drug manufacturing and site changes during the Covid-19 pandemic.

Human Drugs

Acceleron Breakthrough for Pulmonary Hypertension Drug

FDA grants Acceleron Pharma a breakthrough therapy designation for sotatercept and its use in treating patients with pulmonary arterial hypertension.

Human Drugs

Dynamic Stem Cell Marketing Unapproved Biologics

FDA says Dynamic Stem Cell Therapy is marketing unapproved cellular products as treatments for many diseases and conditions.

Human Drugs

Lannett Gets FDA Meeting on Proposed Insulin Biosimilar

Lannett says FDA has granted it a 6/9 Biosimilar Biological Product Development Type 2 meeting to plan next steps for the clinical development of its ...

Human Drugs

Roche NDA Review Extended on Spinal Disorder Drug

FDA extends by three months its review of a Roche NDA for risdiplam and its use in treating spinal muscular atrophy.

Human Drugs

Are FDA EUAs Now Wishful Thinking?

Multiple former FDA officials question the wisdom of the agency granting an emergency use authorization for two malaria medicines to be used against t...

Medical Devices

Pentax Paying $43 Million in Endoscope Case

The Justice Department says Pentax Medical is paying $43 million to resolve criminal charges resulting from its decision not to use revised FDA cleani...

FDA Approves Cipla Generic Proventil HFA

FDA approves Ciplas generic form of Proventil HFA metered-dose inhaler.

Medical Devices

Covid-19 Serology Tests Important Focus: CDRH

CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel discusses the growing importance of serology tests for Covid-19 d...