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

IND application for EB-003 expected in early 2026

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma

Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

Alembic Pharmaceuticals receives EIR for API - I and API - II facility located at Panelav

The inspection was carried out between May 26, 2025 and May 31, 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

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

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