The accelerated approval of Aduhelm is likely to rejuvenate this depleted area, inevitably leading down the long walk to better and better therapies as well as better ways to measure this disease.

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases.

The accelerated approval pathway was established in 1992 to expedite access to new therapies for patients with serious or life-threatening diseases. First created as a strategy to rapidly address ...

But not all drugs work out. Accelerated approvals were withdrawn for about 12% of drugs as of the end of 2021, according to an analysis by Amgen researchers, and that’s not a bad thing. FDA drug ...

New medicines approved through FDA’s accelerated approval pathway 4 have made novel therapeutics for serious or life-threatening conditions available more quickly to the benefit of patients ...

Some recent cancer drug uses that received accelerated approval from the FDA but failed to improve the primary endpoint of overall survival in their post-approval trials were bevacizumab for ...

Second, nothing prevents manufacturers of accelerated approval drugs from charging high prices, often exceeding $10,000 per year, before their products have been proven effective.

In 1992, the FDA instituted accelerated approval regulations, which allow drugs for serious conditions that fill an unmet medical need to be approved based on “surrogate endpoints.” ...

Naci H et al. Characteristics of Pre-Approval and Post-Approval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. JAMA, 2017 DOI: 10.1001/jama.2017.9415 ...

Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases.