RAPS

FDA announces CMC review pilot for drugs with expedited development

FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...
RAPS

FDA wants participants for CMC readiness pilot for expedited drugs

FDA wants participants for CMC readiness pilot for expedited drugs The US Food and Drug Administration (FDA) announced on 11 September a limited chemistry, manufacturing and controls (CMC) development ...

Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary Angioedema

Intellia also separately announced positive topline data today from the Phase 3 HAELO clinical trial of lonvo-z in HAE. The trial met its primary and all key secondary endpoints, demonstrating that a ...
Morningstar

iECURE Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of ECUR-506 Ahead of Planned BLA ...

iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo targeted gene insertion therapies for the treatment of severe, inherited, neurometabolic disorders, today ...

Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy

Alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program – – Positive feedback supports readiness for Phase 3 initiation with manufacturing scale ...
Times Argus

Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel

Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug ...
Seeking Alpha

Lexeo Therapeutics Announces FDA Breakthrough Therapy Designation for LX2006 in Friedreich Ataxia

Breakthrough Therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in cardiac biomarkers and functional measures LX2006 also selected for ...