News about "FDA IND clearance "

Qihan Biotech Secures US FDA IND Clearance for Next-Generation Universal CAR-T Therapy QT-019C

Qihan Biotech Secures US FDA IND Clearance for Next-Generation Universal CAR-T Therapy QT-019C

Qihan Biotech has received US FDA Investigational New Drug clearance for QT-019C, an off-the-shelf universal CAR-T therapy designed to improve safety, accessibility and treatment outcomes for patients with autoimmune diseases.

FDA IND Clearance | 22/05/2026 | By News Bureau 154

FDA Clears IND Application for Chengdu Origen's Gene Therapy Targeting Hypertrophic Cardiomyopathy

FDA Clears IND Application for Chengdu Origen's Gene Therapy Targeting Hypertrophic Cardiomyopathy

Chengdu Origen Biotechnology and Vanotech have received US FDA clearance to begin clinical evaluation of KHN921, a potential first-in-class gene therapy designed to address the genetic root cause of hypertrophic cardiomyopathy linked to MYBPC3 mutations.

FDA IND Clearance | 16/05/2026 | By News Bureau

Vensica Medical Secures US FDA Clearance to Advance Needle-Free OAB Therapy to Phase II

Vensica Medical Secures US FDA Clearance to Advance Needle-Free OAB Therapy to Phase II

Vensica Medical moves forward with clinical trials of its needle-free drug delivery platform aimed at improving access and patient comfort in overactive bladder treatment.

FDA IND Clearance | 01/05/2026 | By News Bureau

Vasa Therapeutics Receives FDA IND Clearance to Advance Novel Small Molecule VS-041

Vasa Therapeutics Receives FDA IND Clearance to Advance Novel Small Molecule VS-041

Vasa Therapeutics plans to immediately initiate a phase-I (c) clinical trial in the US for participants with Heart Failure with Preserved Ejection Fraction (HFpEF).
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FDA IND Clearance | 15/10/2025 | By Dineshwori 341

Senhwa Biosciences Secures US FDA Nod to Advance Pidnarulex Trial for MYC-Driven B-Cell Lymphoma

Senhwa Biosciences Secures US FDA Nod to Advance Pidnarulex Trial for MYC-Driven B-Cell Lymphoma

Senhwa Biosciences has received FDA clearance to begin a Phase 1b/2 trial of its novel MYC-targeting drug candidate Pidnarulex (CX-5461) in patients with B-cell lymphoma, marking a potential breakthrough in precision oncology.

FDA IND Clearance | 06/09/2025 | By Mrinmoy Dey 252


 

 

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