Tiziana Life Sciences files IND application with FDA for ALS Phase 2 trial
Tiziana Life Sciences (TLSA) announced the submission of its Investigational New Drug, IND, application to the U.S. Food and Drug ...
Business Wire21d
Ensoma Receives Rare Pediatric Disease and Orphan Drug Designations for EN-374 for Treatment of Chronic Granulomatous Disease
Ensoma anticipates it will submit an investigational new drug application (IND) for EN-374 in the first half of 2025. Chronic granulomatous disease (CGD) is a rare and severe genetic disorder ...
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 ...
Yahoo Finance1mon
Pluristyx Announces Filing of Drug Master File for PluriBank™ iPSC Lines with U.S. FDA
SEATTLE, February 04, 2025--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master ...
Healio16d
FDA accepts IND for allogenic CAR T-cell therapy that could bypass lymphodepletion
The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic CAR T-cell therapy, paving the way for a phase 1 trial in lupus and other autoimmune diseases.
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Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment
announced today the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration ("FDA") on February 24, 2025, regarding the ...
Morningstar10d
LTZ Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of First-in-Class Myeloid Engager Immunotherapy, LTZ-301
today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for LTZ-301, a first-in-class myeloid engager immunotherapy ...
The Bakersfield Californian1mon
Pluristyx Announces Filing of Drug Master File for PluriBank™ iPSC Lines with U.S. FDA
Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug ...