FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations

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

Brenntag expands partnership with Lallemand to deliver Nutrilife baking enzymes across North America

Brenntag will supply Food & Nutrition customers in the United States and Canada with Lallemand’s renowned Nutrilife baking enzyme range

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