FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Federal Register

Notice on Biosimilar Patent Infringement Complaint

Federal Register notice: FDA provides notice that is has received a copy of a patent infringement complaint that had been filed against a pending bios...

latest-news-card-1
Medical Devices

FreeStyle Sensors for Automated Insulin Delivery

FDA clears an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration wi...

latest-news-card-1
Human Drugs

FDA Increasing Oversight on Diethylene Glycol Contamination

CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products, including cough/cold syrups with di...

latest-news-card-1
Human Drugs

Novartis Petitions FDA on Dosing Titration Info Requirement

Presumably in an attempt to block or delay potential generic Mayzent products, Novartis petitions FDA to make generic versions meet certain requiremen...

latest-news-card-1
Biologics

Priority for Alzheimers sBLA Seeking Traditional Approval

FDA accepts for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to convert the ...

latest-news-card-1
EIRS/483s

DoJ Preferring Deferred Prosecution Agreements: Attorneys

Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more Department of Justice deferred prosecution agreeme...

latest-news-card-1
Human Drugs

Panel to Weigh OTC Phenylephrine Efficacy

FDA announces a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter use of o...

latest-news-card-1
Human Drugs

Exelixis Renal Cell Carcinoma Study Misses Endpoint

Exelixis says its Phase 3 CONTACT-03 study evaluating the companys Cabometyx (cabozantinib) in combination with atezolizumab versus cabozantinib alone...

latest-news-card-1
Federal Register

Drug Continuous Manufacturing Guidance

Federal Register notice: FDA makes available a final guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products.

latest-news-card-1
Federal Register

Guide on Monoclonal Antibody Development

Federal Register notice: FDA makes available a draft guidance entitled Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Pr...