Enforcement Report - Week of May 31, 2023
Fresenius Kabi`s Generic Testosterone Receives Approval In US
Efruxifermin Associated With Improved Glucose Metabolism in Patients
REDWOOD CITY, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases related to chronic glucose imbalance, has been added to the Russell Microcap® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28.
Though review of its six-month implantable glucose sensor has faced FDA delays due to COVID-19, Senseonics was able to deliver clinical data.
Center has released new guidelines for treating Mucormycosis or black fungus disease in children below the age of 18 years.
Intl Medication Sys`s Generic Dextrose API Receives Approval In US
A global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) approval of new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These new Clinimix formulations contain up to 80 g/L of amino acids, the highest protein in any multi-chamber bag available in the U.S.2, making it easier to reach patient protein targets while delivering less fluid and dextrose than provided by existing formulations3,4.
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) approval of new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These new Clinimix formulations contain up to 80 g/L of amino acids, the highest protein in any multi-chamber bag available in the U.S.,2 making it easier to reach patient protein targets while delivering less fluid and dextrose than provided by existing formulations.3,4
Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US