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

Biostar Pharma doses first patient in Phase II/III multiregional trials of utidelone capsule

FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole

FDA approves Corstasis’ bumetanide nasal spray to treat edema in heart, liver, and kidney disease

Galimedix completes phase 1 study with oral small molecule GAL-101

The study further confirmed that GAL-101 effectively crosses the blood-brain barrier

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

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

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav

Fermenta granted process patent for plant-based Vitamin D3

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