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

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

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 ...

The FDA approval for linvoseltamab in R/R MM is based on the pivotal Phase 1/2 LINKER-MM1 trial. In this trial, patients (n=80) experienced a 70% objective response rate (ORR), with 45% achieving ...

ProKidney stated that nearly 50% of patients needed for the eGFR slope analysis are now enrolled, with topline results expected in Q2 2027, which would underpin an accelerated approval application.

The FDA granted accelerated approval of linvoseltamab-gcpt for certain patients with multiple myeloma.Specifically, the approval is for patients with relapsed or refractory multiple myeloma who ...

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 ...

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 ...

Indications with confirmatory trials ongoing at accelerated approval showed shorter completion times (median, 2.78 years) than those without ongoing trials (median, 5.59 years; P < .001).

Provided by PR NewswireMay 29, 2025, 12:00:00 PM Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval ...

FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetesFDA also confirmed that the ongoing Phase 3 ...