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On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide,...
MRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063) compared to KEYTRUDA aloneThe DMFS results
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and...
Aurinia Pharmaceuticals Inc. today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV and Phase 3 AURORA 1 studies, which found that LUPKYNIS® with mycophenolate... | June 1, 2023
Cognitive improvement with Sunosi sustained over eight hours in patients with excessive daytime sleepiness due to obstructive sleep apneaNEW YORK, June 01, 2023 -- Axsome Therapeutics, Inc. , a... | June 1, 2023