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

Zydus receives final approval from USFDA for Leuprolide Acetate injection

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer

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

Hormone therapy for menopause gets green light from FDA

The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature

Novartis opens radioligand therapy facility in Carlsbad, US

Novartis is the only pharmaceutical company with a dedicated commercial RLT portfolio

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

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.

Novartis opens radioligand therapy manufacturing facility in California

New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of >99.9% to patients across western US, Alaska and Hawaii

Synchron raises $200 million to power non-surgical brain interface commercialization

New funding to advance non-surgical brain interface technology and expand clinical and engineering capabilities globally