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

Prasad’s departure, confirmed to Pharmaceutical Technology by a department for Human Health and Services (HHS) spokesperson, ...

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 ...

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

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

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 ...

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 ...

Avidity Biosciences: Three Accelerated Approval Shots Feels Excessive Jul. 14, 2025 4:24 PM ET Avidity Biosciences, Inc. (RNA) Stock RNA 3 Comments Edmund Ingham Investing Group Leader ...

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 ...