The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how the use of biomarkers is ...

Sun Pharma’s INSPIRE-1 and INSPIRE-2 studies met their primary endpoint at Week 24, with Ilumya 100 mg demonstrating superior ...

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, ...

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

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, and patient-centered outcomes in oncology trials.

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, explains how clinical ...

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, 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.