Federal investigators on Wednesday recommended that the U.S. Food and Drug Administration revise its emergency use authorization (EUA) policies for tests to ensure better availability and quality during future infectious disease outbreaks.

FDA

The U.S. Food and Drug Administration has approved Fennec Pharmaceuticals Inc.’s intravenous therapy to prevent chemotherapy-induced hearing loss in children, according to the health regulator’s website.

chicken

Cooking chicken in cough medicine NyQuil is not only silly and unappetizing but can also be very unsafe, the U.S. Food and Drug Administration said, following the “sleepy chicken” TikTok challenge.

FDA

The U.S. Food and Drug Administration on Tuesday warned that certain types of insulin pump systems manufactured by Medtronic were vulnerable to cyberattacks and that hackers could potentially hamper insulin delivery by accessing the device.

FDA

The U.S. Food and Drug Administration’s (FDA) staff on Tuesday raised concerns over the safety of Spectrum Pharmaceutical’s experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%.

FDA sign

The FDA approved bluebird bio’s lentiviral vector (LVV) eli-cel Friday as the first therapy to slow the progression of neurologic dysfunction in juvenile boys with early, active cerebral adrenoleukodystrophy (CALD).

FDA

The agencies announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases.

FDA

Perrigo Co. Plc said on Monday that the U.S. Food and Drug Administration had scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.

FDA

The U.S. Food and Drug Administration has received several reports of certain types of cancers in the scar tissue that forms around breast implants, the agency said in a safety notice on Thursday.

Abbott

The U.S. Food and Drug Administration on Thursday alerted healthcare providers about a potential clip lock issue with Abbott Laboratories’ MitraClip device used to stop heart valve leakage.