FDA concludes Lupin’s Nagpur Unit-1 facility inspection with zero observations

Glenmark posts 72.2% jump in Q2 FY net profit at Rs. 610.4 Cr YoY

EBITDA was Rs. 2,359.6 crore in the quarter ended September 30, 2025

Medico Remedies gets GMP compliance certificate from SMDC, Ukraine

SMDC is a participating authority under Pharmaceutical Inspection Cooperation Scheme (PIC/S)

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

FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue

Teva’s AUSTEDO and AUSTEDO XR demonstrate real-world improvement in patients with tardive dyskinesia

The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life

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

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline

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