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Medical Devices

Qiagen EUA for Rapid Covid Antigen Test

FDA grants Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process an average of around...

Biologics

Genzyme BLA Approved for Pompe Disease

FDA has approved a Genzyme BLA for Nexviazyme for intravenous infusion to treat patients one year of age and older with late-onset Pompe disease.

Medical Devices

Class 1 Recall on Boston Scientific Pacemakers

FDA classifies as Class 1 a Boston Scientific recall of its Ingenio pacemakers and CRT-Ps due to safety mode transition error.

Human Drugs

Guide on Near Infrared Analytical Procedures

FDA releases a final guidance on Development and Submission of Near Infrared Analytical Procedures.

Federal Register

FDA Implementing Fallout from Drug/Device Case

Federal Register notice: FDA announces its implementation of a court decision that ruled the agency is not afforded discretion when a combination prod...

Federal Register

MOU Period Extended for Compounded Drugs

Federal Register notice: FDA extends the period for states to decide whether to sign the final standard memorandum of understanding for compounded dru...

Human Drugs

Spectrum Given Complete Response on Rolontis

FDA sends Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related to manufacturing an...

Medical Devices

Boston Scientific Trial on Pulmonary Embolism Therapy

Boston Scientific begins enrolling in the HI-PEITHO clinical trial to compare its EkoSonic Endovascular System in combination with anticoagulation the...

Human Drugs

Academics Challenge FDA Suicidality Drug Warning

Researchers call on FDA to reconsider class suicide risk warnings for all epilepsy drugs.

Human Drugs

Apexigen Orphan Status for Sarcoma Therapy

FDA grants Apexigen an orphan drug designation for APX005M (sotigalimab) for treating soft tissue sarcoma.