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FDA IND

Pharma & Biotech

ReST Therapeutics wins FDA IND acceptance for RST-101 as early PTSD treatment strategy enters human testing

ReST Therapeutics’ RST-101 enters human testing for early PTSD. Find out why this IND acceptance could reshape trauma care.

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Pharma & Biotech

Can Brenus Pharma crack the cold-tumor problem in metastatic colorectal cancer?

Find out how Brenus Pharma’s STC-1010 FDA IND acceptance could reshape MSS colorectal cancer immunotherapy development.

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Pharma & Biotech

HBM7004 FDA clearance gives Harbour BioMed a fresh solid tumor immunotherapy test

Solid tumor T-cell engagers still face safety limits. Harbour BioMed’s HBM7004 now tests whether B7-H4 can widen that window.

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Medical Devices & Diagnostics

Trace Biosciences’ LGW16-03 IND approval opens new chapter in nerve-targeted surgical imaging

Trace Biosciences receives IND approval for LGW16-03. Find out what this means for nerve imaging and the future of surgical precision.

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Pharma & Biotech

Avacta Therapeutics (LSE: AVCT) advances FAP-targeting drug conjugate AVA6103 into Phase 1: What’s at stake?

Avacta Therapeutics (LSE: AVCT) has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration for AVA6103 (also known as FAP-Exd), its second clinical-stage asset developed using the company’s proprietary pre|CISION platform. The IND clearance enables the start of a Phase 1 trial evaluating the safety, tolerability, and dose parameters of

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Pharma & Biotech

Can AB-1009 reshape treatment for late-onset Pompe? AskBio prepares for first patient in U.S.

AskBio’s AB-1009 gene therapy for late-onset Pompe secures FDA IND clearance. Find out what this milestone means for AAV innovation and patient outlook.

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Pharma & Biotech

MH002 enters phase 2b: Can MRM Health’s live biotherapeutic consortium redefine ulcerative colitis treatment standards?

MRM Health's MH002 enters phase 2b for ulcerative colitis. Can this live biotherapeutic redefine immune-sparing treatment in IBD? Find out what’s at stake.

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Pharma & Biotech

Mabwell’s anti-ST2 antibody 9MW1911 cleared for U.S. Phase IIa trial: Could this reshape COPD biologics?

Mabwell Biopharmaceuticals has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration to initiate a Phase IIa clinical study for its anti-ST2 monoclonal antibody, 9MW1911, in patients with moderate-to-severe chronic obstructive pulmonary disease. This regulatory milestone comes on the heels of a completed Phase IIa study in China, where Mabwell

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Pharma & Biotech

T-MAXIMUM’s MT027 clears FDA hurdle for glioblastoma in major step for solid tumor CAR-T

T-MAXIMUM’s MT027 CAR-T therapy for glioblastoma enters Phase II after FDA clearance. Find out what this means for solid tumor cell therapy.

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