Istituzioni

Coronavirus (COVID-19) Update: December 21, 2021

The FDA, along with the CDC and our state and local partners, are working to investigate a multistate outbreak of Listeria monocytogenes infections.

FDA conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs.

FDA has authorized marketing of the first laser-based device for removal of Inferior Vena Cava (IVC) filters. An IVC filter is a small cage-like device inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs.

Today, the FDA approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Today, the FDA approved Vyvgart for the treatment of generalized myasthenia gravis in certain adults

Coronavirus (COVID-19) Update: December 17, 2021

The FDA approved the first drug for the prevention of acute graft versus host disease, a condition that occurs when donor bone marrow or stem cells attack the graft recipient, in combination with certain immunosuppressants.

Coronavirus (COVID-19) Update: December 14, 2021

Coronavirus (COVID-19) Update: December 10, 2021

Today, the FDA published a discussion paper regarding 3D printing medical devices at the point of care (PoC), such as hospitals and doctor’s offices.

The FDA amended the emergency use authorizations for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses

The FDA authorized new long-acting monoclonal antibodies for the pre-exposure prevention of COVID-19 in certain adults and pediatric individuals.

Coronavirus (COVID-19) Update: December 7, 2021

Today, the FDA issued guidances focused on the development of treatments to target genetic diseases, based on an individual patient’s genes. These draft guidances, once finalized, are aimed at helping treatments reach patients in a timely manner.

FDA revised the EUA of bamlanivimab and etesevimab, administered together, to treat mild to moderate COVID-19 in all younger pediatric patients, including newborns. The drug combination is also now authorized for post-exposure prevention of COVID-19 in all pediatric patients, including newborns.

The FDA issued a proposed rule that aims to enhance the safety of produce and if finalized would require certain farms to evaluate potential contamination risks for the water used on crops before harvest and take additional mitigation measures to help protect public health.

Coronavirus (COVID-19) Update: November 30, 2021

FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.