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3381 News Found

USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
Policy | January 16, 2025

USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats


PM Modi lays foundation stone of Kris City and bulk Drug Park at Nakkapalli
News | January 09, 2025

PM Modi lays foundation stone of Kris City and bulk Drug Park at Nakkapalli

The project is set to attract significant manufacturing investments of approximately Rs. 10,500 crore and is also projected to create around 1 lakh direct and indirect jobs


Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections
Drug Approval | January 02, 2025

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria


Huadong Medicine and SynerK to jointly develop a novel siRNA drug SNK-2726
R&D | January 02, 2025

Huadong Medicine and SynerK to jointly develop a novel siRNA drug SNK-2726

SynerK owns intellectual property rights of SNK-2726, which is currently in the IND filing preparation stage


Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval | December 26, 2024

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP


NTC presents positive results from Phase II Mirakle study evaluating an innovative drug for bacterial conjunctivitis
News | December 07, 2024

NTC presents positive results from Phase II Mirakle study evaluating an innovative drug for bacterial conjunctivitis

Despite NTC014, due to its simplified therapeutic regimen, has been administered at a lower posology than the antibiotic comparator


Converge Bio raises $5.5M Seed to speed up drug discovery and development with Generative AI
Digitisation | November 22, 2024

Converge Bio raises $5.5M Seed to speed up drug discovery and development with Generative AI

Bringing a new drug to market takes about 10 years and requires an investment of approximately $1 billion


Siegfried opens global R&D Center for Drug Substances in Switzerland
News | November 21, 2024

Siegfried opens global R&D Center for Drug Substances in Switzerland

The new facility significantly increases Siegfried’s R&D capacity to drive development excellence and further growth


Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals
News | November 20, 2024

Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals

Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities