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FDA approves innovative treatment for pediatric patients with congenital athymia

Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S.

"Today's action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.

FDA authorizes software that can help identify prostate cancer

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body).

FDA advances data, IT modernization efforts with new office of digital transformation

Today, the U.S. Food and Drug Administration announced the reorganization of the agency's information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level.

ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

FDA approves first COVID-19 vaccine

The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

FDA approves new treatment for Pompe disease

Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease.

Patients with Pompe disease have an enzyme deficiency that leads to the accumulation of a complex sugar, called glycogen, in skeletal and heart muscles, which cause muscle weakness and premature death from respiratory or heart failure.

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.

Regulatory Affairs News

FDA approves innovative treatment for pediatric patients with congenital athymia

FDA authorizes software that can help identify prostate cancer

FDA advances data, IT modernization efforts with new office of digital transformation

ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

FDA approves first COVID-19 vaccine

FDA approves new treatment for Pompe disease

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

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