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
The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life
While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Poviztra is a second brand of Wegovy
The said inspection concluded with Zero Form 483 observation
Syngene International has reported total income of Rs. 926 crore during the period ended September 30, 2025
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals
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