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425 - two (0001843988) (Subject)
For Immediate Release: May 04, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA Center for Drug Evaluation and Research (CDER) continually monitors our ability to meet user fee commitments. To maintain transparency during the COVID-19 public health emergency, CDER posts periodic updates to the CDER’s Work to
For Immediate Release: April 30, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On April 28, the FDA approved an abbreviated new drug application (ANDA) for 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) single dose vial, indicated as an additive in parenteral (injection) fluid therapy for use in pat
For Immediate Release: April 30, 2021 Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. “Chronic kidney disease is an important public health issue, and there is a signif