FDA Related News

Human Drugs

Panel Backs Accelerated OK Consideration of Biogen's ALS Drug

An FDA advisory committee votes 9 to 0 that Biogens amyotrophic lateral sclerosis drug tofersen should be considered for accelerated approval.

FDA Digital Health Technologies Framework

As required by the PDUFA 7 agreement, FDA publishes a framework for how it will implement a multifaceted program for using digital health technologies...

Medical Devices

Xtrava Covid Test Less Effective with Some Variants: FDA

FDA adds the Xtrava Health SPERA Covid-19 test to the list of tests expected to have a reduced performance with certain Covid-19 Omicron sub-variants.

Medical Devices

Unibody Endografts Dont Beat Older Ones: Study

FDA-funded research finds that unibody endografts are not non-inferior to non-unibody devices, leading to updated FDA labeling.

Medical Devices

FDA Reminds on Recalled Exactech Joint Devices

FDA reminds patients and healthcare providers about risks associated with recalled Exactech replacement joint devices that were packaged in defective ...

Human Drugs

Dupixent Meets Key Phase 3 Endpoints: Regeneron

Regeneron and Sanofi say an investigational Phase 3 trial of Dupixent in some COPD patients met all key primary and secondary endpoints.

Biologics

Workforce, Education for Regenerative Medicine

The Government Accountability Office reports on regenerative medicine and advanced therapies workforce and education/training needs.

FDA General

OSTP Goals for Biotechnology and Biomanufacturing

A new White House Office of Science and Technology Policy (OSTP) report lists 10 bold goals for the U.S. biotechnology and biomanufacturing.

Medical Devices

Device Cybersecurity is Top Concern for Shuren

CDRH director Jeff Shuren tells an Alliance for Stronger FDA Webinar that cybersecurity is one of the biggest concerns that keeps him up at night.

Human Drugs

Cidar/Melintas Rezzayo Wins FDA Approval

FDA approves a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and invasive candidiasi...