Risultati per: FDA approva un nuovo trattamento per l’emicrania

Il presidente Nistico’: “In 3 mesi smaltite centinaia di pratiche”

Il presidente Nistico’: “In 3 mesi smaltite centinaia di pratiche”

This Viewpoint from the FDA discusses how pragmatic clinical research—assessment that uses real-world data, often in combination with research data, after initial marketing approval—can help in evaluation of new technologies, benefit research sites in underresourced settings, and better inform regulatory decisions and clinical practice.

The US Food and Drug Administration (FDA) will begin supervising laboratory-developed tests more closely due to concerns that they do not always provide accurate results, the agency recently announced.

La Commissione europea ha concesso l’autorizzazione per l’insulina settimanale, Awiqli di Novo Nordisk, la prima al mondo indicata per il trattamento del diabete negli adulti. «Il farmaco – spiega una nota – è progettato per coprire il fabbisogno di insulina basale per un’intera settimana con una singola iniezione sottocutanea ed è stato approvato per gli adulti con diabete mellito»

This Viewpoint examines the appropriateness of FDA accelerated approval of novel gene therapies to treat boys with Duchenne muscular dystrophy following clinical trials with surrogate outcomes that did not demonstrate net benefits.

This Viewpoint outlines the potential effects of the Supreme Court case regarding mifepristone restrictions: a decision for the FDA would allow current dispensing, while ruling against the FDA would severely curtail access to reproductive health options.

The US Food and Drug Administration (FDA) recently approved resmetirom, marketed as Rezdiffra, for adults with nonalcoholic steatohepatitis (NASH) without cirrhosis. NASH is a progressive fatty liver disease that affects up to 8 million people in the US and can cause liver inflammation and scarring, known as fibrosis. Resmetirom, an oral drug that reduces the accumulation of liver fat, can be used along with diet and exercise, which are the standard care for patients with NASH.

This cohort study assesses the validity of molecular targets and therapeutic benefits of US Food and Drug Administration (FDA)–approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.