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Investigational New Drug (IND)
An IND application is a request for authorization from the FDA ... of detail needed for the IRB and/or FDA to make a determination. Learn more on the FDA process Here is where differences become our ...
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Investigational Products: Overview
From the time an IND application is submitted to the FDA until the IND ... and when Tracking through a change control process all amendments to FDA-cleared IND applications, such as new protocols or ...
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Humacyte To Submit IND Application For Small-Diameter ATEV In Coronary Bypass Surgery
Tuesday announced its plan to file an Investigational New Drug or IND application with the U.S. FDA in 2025 to support a first-in-human clinical study of its small-diameter acellular tissue ...
Business Wire10d
LTZ Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of First-in-Class Myeloid Engager Immunotherapy, LTZ-301
REDWOOD CITY, Calif. & SHENZHEN, China--(BUSINESS WIRE)--LTZ Therapeutics, an immunotherapy-focused biotech company, today announced that the U.S. Food and Drug Administration (FDA) has cleared ...
Business Wire29d
Aro Biotherapeutics Announces U.S. FDA Clearance of IND Application for ABX1100 for Potential Treatment of Late-Onset Pompe Disease (LOPD)
“FDA clearance of our IND application, combined with the encouraging data from our phase 1 healthy volunteer trial, provide tremendous momentum for the ABX1100 clinical development program ...
Morningstar10d
LTZ Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of First-in-Class Myeloid Engager Immunotherapy, LTZ-301
has cleared the company’s Investigational New Drug (IND) application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma (r ...