The U.S. Food and Drug Administration (FDA) approved six new therapies in December 2025 for blood cancers, prostate cancer, ...

The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis. Although the application was filed under the ...

AstraZeneca will voluntarily take its anticoagulant reversal agent Andexxa off the market in the US in light of FDA concerns ...

The HHS OIG report calls for improved FDA oversight of the accelerated approval pathway, focusing on timely confirmatory trials and financial impacts on Medicare and Medicaid. Chelsee Jensen ...

Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved Modeyso for patients with H3 K27M-mutant diffuse midline glioma. The therapy showed an overall ...

The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives?

The time between accelerated approval and first reporting of negative confirmatory trial results ranged from 1 year to more than 9 years. There may be “substantial delays” between when a drug is ...

The US Food and Drug Administration (FDA) released a draft guidance this week that aims to improve the accelerated approval pathway for oncology drugs. The draft guidance, published in the Federal ...