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
Organic capex during the quarter amounted to Rs. 491.1 crore, supporting ongoing business expansion initiatives
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
Relmada expects to initiate its Phase 3 program in the first half of 2026
The said inspection concluded with Zero Form 483 observation
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
This latest commitment brings the British pharmaceutical company’s total investment at the site to $886 million
Comirnaty, Pfizer’s COVID-19 prevention vaccine, reported global sales of $1.15 billion
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