Lupin receives EIR from FDA for its Aurangabad facility

The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.

Revvity launch new somatic cancer reference standards to to boost precision in oncology diagnostics

The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

Granules Life Sciences receives first FDA approval for Hyderabad facility

SOUKYA launches Rs. 125 crore, 100-bed AYUSH hospital in Bengaluru

The upcoming facility marks a strategic milestone in SOUKYA’s mission to make evidence-based holistic healthcare

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets