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

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

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

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 ...

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 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 ...

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 ...

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

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 ...

Avidity Biosciences Announces the Accelerated Approval Regulatory Pathway in the U.S. is Open for Del-Brax and Initiates the Global, Confirmatory Phase 3 FORWARD™ Study in FSHD ...

ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20insApproval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which ...