Author name: Leonardo Arias

Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.

The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.

A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals.

Stephen Hemsley is the chairman of UnitedHealth’s board and its CEO. The Accountability Board says that undercuts corporate governance at a turbulent time for the company.

The Sanofi partnership will support clinical validation and regulatory submissions for Revvity’s new assay. Elsewhere, Kihealth raised $5 million in seed funding to launch its early detection test.

Desde la formulación de los medicamentos que consumimos hasta la limpieza de espacios públicos, los productos químicos son protagonistas silenciosos en nuestro día a día. Su correcta selección y aplicación son cruciales para garantizar la seguridad, e …

About 41% of beneficiaries who could lose coverage due to federal work requirements signed into law this summer have three or more chronic conditions, according to the study in JAMA.

However, a prolonged lapse in funding could affect other activities underpinning implementation of the law that holds consumers blameless for unexpected out-of-network bills.

Rocket Pharmaceuticals’ strategic realignment initiative in July pulled funding from fanca-cel, which the biotech was developing for Fanconi anemia.

This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.