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 ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

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 ...

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 ...

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

“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...

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 ...

Atrasentan reduced urine protein-to-creatinine ratio by 38% compared with 3% for placebo at week 36. The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) ...

The US Food and Drug Administration (FDA) released a draft guidance this week that aims to improve the accelerated approval pathway for oncology drugs. The draft guidance, published in the Federal ...