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Results For "Investigational-New-Drug"

84 News Found

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
News | August 28, 2025

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS

As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya


AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease
Biotech | August 16, 2025

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations


Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys
Drug Approval | July 21, 2025

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths


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
Clinical Trials | 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