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Results For "Investigational-New-Drug"

53 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


SPARC announces submission of IND Application for SBO-154 to USFDA
News | April 04, 2025

SPARC announces submission of IND Application for SBO-154 to USFDA

The IND application supports the next phase of development of SBO-154


Novo Nordisk strikes $1bn deal for Lexicon’s oral obesity drug
News | March 29, 2025

Novo Nordisk strikes $1bn deal for Lexicon’s oral obesity drug

Lexicon Pharmaceuticals announces exclusive license agreement with Novo Nordisk for LX9851


AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma
News | January 17, 2025

AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma

SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3


Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107
Diagnostic Center | January 09, 2025

Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107

The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs


AstraZeneca completes equity investment agreement with Cellectis
News | May 08, 2024

AstraZeneca completes equity investment agreement with Cellectis

Cellectis is also eligible to receive an investigational new drug (IND) option fee and development


MIRA Pharmaceuticals announces collaboration with Pharmaseed
News | February 08, 2024

MIRA Pharmaceuticals announces collaboration with Pharmaseed

Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024


Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug
News | December 07, 2023

Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug

Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya


Keytruda+ chemotherapy improves overall survival versus chemotherapy alone for unresectable advanced pleural mesothelioma
Diagnostic Center | June 05, 2023

Keytruda+ chemotherapy improves overall survival versus chemotherapy alone for unresectable advanced pleural mesothelioma

In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone