Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities

The observations are procedural in nature and will be responded to within the stipulated time

Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis

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

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

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations