Retail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...

Prasad’s departure, confirmed to Pharmaceutical Technology by a department for Human Health and Services (HHS) spokesperson, ...

As July concludes, the landscape of hematologic oncology continues to evolve, with notable progress in multiple myeloma, ...

The analysis of FDA-approved next-in-class drugs also found that, among RCTs with head-to-head trials, fewer than 1 in 4 of ...

Jacob Sands, MD, discusses the data that support the FDA accelerated approval of Dato-DXd in EGFR-positive non–small cell ...

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 ...

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.

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 Accelerated approvals were withdrawn for about 12% of drugs as of the end of 2021, according to an analysis by Amgen researchers, and that’s not a bad thing.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

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 ...

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.