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Results For "Investigational-New-Drug"

82 News Found

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy
Clinical Trials | January 12, 2026

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms


Alveus Therapeutics launches with $159.8m Series A to advance next-gen obesity drugs
Biotech | January 11, 2026

Alveus Therapeutics launches with $159.8m Series A to advance next-gen obesity drugs

ALV-100 is a bifunctional fusion protein combining glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonism with glucagon-like peptide-1 receptor agonism


Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
Clinical Trials | January 08, 2026

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety


Medera doses final patient in high-dose HFpEF gene therapy trial
Biopharma | January 07, 2026

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide


Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China
Biopharma | January 07, 2026

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001


FibroBiologics moves experimental psoriasis therapy into FDA review
News | January 04, 2026

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline


CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers
Clinical Trials | December 31, 2025

CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers

The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively


Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial
Clinical Trials | December 29, 2025

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial

Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis


InnoCare Pharma gets green light for Phase II trial of oral lupus drug
Clinical Trials | December 27, 2025

InnoCare Pharma gets green light for Phase II trial of oral lupus drug

CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions


Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613
Biopharma | December 24, 2025

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.