News | November 15, 2025
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
The observations are procedural in nature and will be responded to within the stipulated time
Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis
OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue
The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
Sumatriptan injection is indicated in adults for the acute treatment of migraine
RedHill has obtained a court-approved asset attachment in South Korea to prevent Kukbo from transferring or disposing of assets ahead of enforcement of the judgment
Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde
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