In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how ...

The FDA’s green light for a Phase II trial (JSKN003-202) of JSKN003 accelerates efforts to address platinum-resistant ovarian and related gynecologic cancers.

In this video interview, Michael Miller, chief operating officer at Quanterix, highlights neurology and oncology as two therapeutic areas experiencing major advances from biomarker integration, from ...

In this video interview, Michael Miller, chief operating officer at Quanterix, outlines key technical and regulatory considerations for clinical operations professionals integrating biomarkers into ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and ...

Key takeaways J&J has submitted an sBLA to the FDA seeking to update Tremfya’s label to include data on inhibiting structural joint damage in adults with active PsA. Phase IIIb APEX trial results ...

AbbVie has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Venclexta (venetoclax) in combination with acalabrutinib in previously untreated patients with chronic ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced executive orders can influence federal funding decisions, prompting ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research teams to closely scrutinize federal fund certifications and document ...

A new myTomorrows survey of physicians in the United States highlights the need for smarter, AI-driven tools to overcome inefficiencies in clinical trial access and improve patient care timelines.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

Results from the Phase III PREVAIL trial showed that gefurulimab, a dual-binding nanobody developed by Alexion, AstraZeneca Rare Disease, led to statistically significant and clinically meaningful ...