Food and Drug Administration – Page 22

Bird Flu Outbreak in Cattle May Have Begun Months Earlier Than Thought

A single spillover, from a bird to a cow, led to the infections, a review of genetic data has found.

By Apoorva Mandavilli

Deaths (Fatalities) Elderly Food and Drug Administration Heart impella Implants Johnson & Johnson Medical Devices Recalls and Bans of Products

FDA Issues Alert on Heart Pump Linked to Deaths

The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart.

By Christina Jewett

Clinical Trials Cohen, Joshua B Drugs (Pharmaceuticals) Food and Drug Administration Klee, Justin United States

A.L.S. Drug Relyvrio Fails Clinical Trial and May Be Withdrawn From the Market

Leaders of the treatment’s manufacturer, Amylyx, said they would announce their plans for it within eight weeks.

By Pam Belluck

donanemab Drugs (Pharmaceuticals) Eli Lilly and Company Food and Drug Administration

F.D.A. Delays Action on Closely Watched Alzheimer’s Drug

Eli Lilly’s donanemab was expected to be approved this month, but the agency has decided to convene a panel of independent experts to evaluate the drug’s safety and efficacy.

By Pam Belluck