Istituzioni

The FDA today approved Cytalux, an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

The FDA approved the first drug for treating adults and pediatric patients with post-transplant cytomegalovirus infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for cytomegalovirus.

Coronavirus (COVID-19) Update: November 23, 2021

The FDA approved a drug to improve growth in children five years of age and older with achondroplasia and open growth plates, meaning these children still have the potential to grow. Achondroplasia is the most common form of dwarfism.

Today, the FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than the PMA pathway.

The FDA amended the emergency use authorizations for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

The FDA, along with the CDC and our state and local partners, are working to investigate a multistate outbreak of E.coli O157:H7.

Coronavirus (COVID-19) Update: November 16, 2021

The FDA authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

Today, the U.S. Food and Drug Administration is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests.

he FDA approved a new drug to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The drug is the first FDA-approved option patients can take regardless of previous therapies.

Today, the FDA is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines.

Coronavirus (COVID-19) Update: November 12, 2021

Coronavirus (COVID-19) Update: November 5, 2021

The FDA is making available the draft guidance Content of Premarket Submissions for Device Software Functions intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions

Coronavirus (COVID-19) Update: November 2, 2021

Coronavirus (COVID-19) Update: October 29, 2021

FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.

FDA, NIH, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.

FDA took actions with new orders and labeling for all approved breast implants and updated post-approval study data.