Latest news and insights on the pharmaceutical industry | Indian Pharma Post

Results For "Investigational-New-Drug"

82 News Found

Suven Life Sciences announces FDA acceptance of investigational new drug
Drug Approval | August 30, 2024

Suven Life Sciences announces FDA acceptance of investigational new drug

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology


FDA pushes forward on gene-editing therapies with new safety roadmap
Biotech | April 20, 2026

FDA pushes forward on gene-editing therapies with new safety roadmap

Genome editing holds extraordinary promise for treating previously incurable genetic diseases


GlycoNex wins Japan nod to launch first human trial of lead program in gastrointestinal cancers
Clinical Trials | April 16, 2026

GlycoNex wins Japan nod to launch first human trial of lead program in gastrointestinal cancers

The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy


Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy
Biotech | March 31, 2026

Biocytogen partner NEOK Bio gets FDA nod for novel cancer therapy

The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors


Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
News | February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway


Eyestem moves closer to blindness breakthrough with phase 2 trial green light
R&D | January 29, 2026

Eyestem moves closer to blindness breakthrough with phase 2 trial green light

The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity


Bayer and Vanderbilt launch five-year partnership to accelerate innovative therapies
R&D | January 23, 2026

Bayer and Vanderbilt launch five-year partnership to accelerate innovative therapies

The partnership initially will focus on cardiovascular and kidney diseases


4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy
Drug Approval | January 12, 2026

4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy

Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function


Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment
Biotech | January 12, 2026

Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment

CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration