Retail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...

Q2 2025 Management View Stéphane Bancel, CEO, highlighted, “In the second quarter, our revenues of $2.1 billion and a loss of $0.8 billion were in line with our expectations, and they reflect the ...

On July 2, linvoseltamab-gcpt (Lynozyfic; Regeneron) received an accelerated approval from the FDA in relapsed/refractory ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

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

As July concludes, the landscape of hematologic oncology continues to evolve, with notable progress in multiple myeloma, ...

The surrogate endpoint for accelerated approval is eGFR slope, and the primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL ...

Jacob Sands, MD, discusses the data that support the FDA accelerated approval of Dato-DXd in EGFR-positive non–small cell ...

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 ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

The Real-World Evidence in the Citizens’ Petition Supports the Accelerated Approval of the Stem Cell Therapy that Was Helping People with ALS Live Longer and Breathe Better ...