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
Venus Remedies now has 29 active product approvals in Vietnam alone
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 approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline
Sumatriptan injection is indicated in adults for the acute treatment of migraine
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
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
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