News

Based on additional results from the Phase III PSMAfore clinical trial, the therapy is now approved for use prior to chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer.

The Phase III MITIGATE trial demonstrated that Uplizna (inebilizumab) significantly reduces the risk of flares, lowers glucocorticoid dependence, and increases rates of treatment- and glucocorticoid-free remission in patients with immunoglobulin G4-related disease.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), shares his thoughts on the recent funding cuts made by the NIH and how they are impacting medical research.

Andrew Mackinnon, Executive GM, Medable, discusses how AI-driven innovations are streamlining clinical trials through enabling scalable operations.

Solriamfetol achieved the primary and key secondary endpoint of the Phase III FOCUS trial by significantly lowering attention-deficit hyperactivity disorder symptoms and disease severity in adults compared to placebo, with a favorable safety and tolerability profile.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses industry’s next steps in being able to maximize the benefits of virtual models.

Compared to osimertinib, Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) significantly extended overall survival.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, highlights how addressing these challenges can aid industry in moving more towards the future.

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis based on positive findings from multiple Phase III trials.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, talks traditional research methods in clinical trials and why industry leaders remain reliant on them.

Survey from the Site Council gathered insights from its members on the quality of site coordinator work.

Phase III VERITAC-2 trial results show vepdegestrant significantly improved progression-free survivalcompared to fulvestrant in patients with ESR1-mutant (ESR1m) advanced or metastatic breast cancer, but did not achieve statistical significance in the overall intent-to-treat population.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the industry's willingness to adopt technology.

Understanding the benefits and concerns associated with implementing datasets into clinical trial workflows.

Phase III IMvoke010 trial found that maintenance treatment with Tecentriq (atezolizumab) did not significantly improve survival compared with placebo in patients with locally advanced squamous cell carcinoma of the head and neck following multimodal definitive treatment.

Andrew Mackinnon, executive GM, Medable, explains how the company ensures high patient participation and data accuracy in decentralized trials.

Intrathecal onasemnogene abeparvovec (OAV101 IT), an investigational, one-time gene replacement therapy, demonstrated a statistically significant improvement in HFMSE in the Phase III STEER study.

COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

The pivotal Phase III study in myasthenia gravis met its primary endpoint with meaningful improvements in MG-ADL across both higher and lower dose arms.

Phase III DIPPER trial shows that adjuvant camrelizumab administered after induction-concurrent chemoradiotherapy significantly improved event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma, along with a favorable safety profile.

In this video interview, Cameron Breze, product manager, Inovalon, discusses the need for accurate information in creating useful clinical data.

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to-severe Sjögren’s disease, which could be the first FcRn blocker ever approved for the autoimmune condition.

In this video interview, Cameron Breze, product manager, Inovalon, talks clinical technology and how the industry is working to increase comfortability with its implementation.

New data from the Phase II RAINFOL-01 study shows rinatabart sesutecan (Rina-S), an investigative antibody-drug conjugate, demonstrated a confirmed objective response rate of 55.6%.

In this video interview, Cameron Breze, product manager, Inovalon, discusses current challenges with patient recruitment and how a combination of technology and manual effort can help improve efficiency.

In the Phase III MIRASOL trial, Elahere (mirvetuximab soravtansine-gynx) significantly improved progression-free survival and overall survival compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer.