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A later congressional investigation described an unusually close collaboration between FDA staff and Biogen during the review.In 2022, an FDA panel rejected the ALS drug Relyvrio for weak data, then reversed course after ALS patients lobbied hard at a second meeting

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Furthermore, in the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths ( In addition, in the EMPEROR-reduced trial, enrolling about 3700 patients affected by heart failure with reduced ejection fraction (HFrEF), empagliflozin significantly reduced the risk of heart failure hospitalization and decreased total hospitalization for HF regardless of the presence of diabetes or baseline levels of glycohemoglobin (HbA1c) ( Since the SGLT2-i benefits on HF could not be explained by anti-hyperglycemic action in any of these trials, multiple hypotheses have been raised about the potential mechanisms underlying their cardiovascular favorable effects