BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and Strategic Transaction to Advance Global Phase 3 DUBLIN-4 Trial Toward ...

FDA Fast Track designation represents an important regulatory milestone for the Plinabulin and docetaxel combination as an anticancer regimen in 2L/3L advanced or metastatic non-squamous NSCLC without ...

BeyondSpring Secures FDA Fast Track Designation for Plinabulin as DUBLIN-4 Phase 3 Trial Advances

BeyondSpring received FDA Fast Track designation for Plinabulin plus docetaxel in post-ICI non-squamous NSCLC and announced a strategic transaction designed to reduce the cash required to advance its ...
Cure Today

FDA Fast Tracks HDP-101 For Multiple Myeloma

HDP-101, an ADC, received FDA fast track designation for multiple myeloma, highlighting its potential in addressing unmet medical needs. Phase 1/2a trials show HDP-101's promising efficacy and ...
Monthly Prescribing Reference

FDA Fast Tracks PTC518 for Huntington Disease

PTC518 was granted Fast Track designation based off strong 12-month interim data on safety and efficacy. The Food and Drug Administration (FDA) has granted Fast Track designation to PTC518 for the ...
Monthly Prescribing Reference

FDA Fast Tracks Novel Intra-Articular Therapy for Osteoarthritis Knee Pain

Compared with placebo, patients who received MM-II had clinically meaningful and sustained pain relief for up to 26 weeks. The Food and Drug Administration (FDA) has granted Fast Track designation to ...
Healio

FDA fast tracks SAR402663 intravitreal gene therapy for wet AMD

Please provide your email address to receive an email when new articles are posted on . SAR402663 is a one-time intravitreal gene therapy designed to reduce treatment burden. It is currently being ...