Results from the Phase III PREVAIL trial (NCT05556096) of gefurulimab demonstrated a statistically significant and clinically ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how recent executive ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical ...

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, discusses the importance ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced ...

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...

Results from a retrospective study found that Amtagvi (lifileucel) achieved a 48.8% objective response rate in patients with ...

Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia ...

Astegolimab met its primary endpoint in the Phase IIb ALIENTO trial with a 15.4% reduction in annualized exacerbation rate at 52 weeks, while the Phase III ARNASA study showed a 14.5% reduction and ...