Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 5

Results For "U.S.-Food-and-Drug-Administration"

560 News Found

FDA approves Merck's Keytruda injection for cancer therapy
Drug Approval | September 21, 2025

FDA approves Merck's Keytruda injection for cancer therapy

Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute


Enveric clears FDA feedback milestone, prepares IND submission for EB-003
Clinical Trials | September 17, 2025

Enveric clears FDA feedback milestone, prepares IND submission for EB-003

IND application for EB-003 expected in early 2026


FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers
Drug Approval | September 16, 2025

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo


Biocartis receives FDA approval for Idylla CDx MSI test
News | September 16, 2025

Biocartis receives FDA approval for Idylla CDx MSI test

First fully automated, cartridge-based companion diagnostic test for colorectal cancer patients approved in the United States


Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China
Drug Approval | September 15, 2025

Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China

This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis


iRegene Therapeutics secures series B+ financing
Biotech | September 12, 2025

iRegene Therapeutics secures series B+ financing

NouvNeu001 is the world’s first allogeneic iPSC-derived cell therapy for Parkinson’s disease to receive this designation