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 ...

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

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 ...

Accelerated approval may be a worthwhile option for sponsors looking to get a product on the market and into patients' hands as soon as possible, but it is far from foolproof. If FDA's decision on ...

References Office of the HHS Inspector General. How FDA used its accelerated approval pathway raised concerns in 3 of 24 drugs reviewed OEI-01-21-00400. HHS. January 2025.

Our measurement of the time to withdraw an accelerated approval versus convert it to a regular approval was also dependent on only one of the FDA's accelerated approvals databases, the CDER list ...

[5] See Richard G. Frank, Mahnum Shahzad & Ezekiel J. Emanuel, Accelerated Approval of Cancer Drugs: No Economic Reward for Drug Makers That Conduct Confirmatory Trials, 41 Health Affs. 1273 (2022).

News and Analysis Published: 31 October 2011 Accelerated approval dust begins to settle Asher Mullard Nature Reviews Drug Discovery 10, 797–798 (2011) Cite this article ...