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FDA News
Tenapanor Nixed By FDA, Citing Deficiencies in Application
July 21, 2021
Citing deficiencies within the New Drug Application submitted for tenapanor for use in patients with chronic kidney disease, the US FDA issued a letter to Ardelyx noting these deficiencies “preclude discussion” related to labeling and post-marketing requirements.
Roxadustat Receives Negative Vote from FDA Panel Ahead of PDUFA Date
July 19, 2021
The FDA's CRDAC July 15 meeting concluded with committee members voting against recommending the approval of roxadustat for the treatment of anemia in adult patients with chronic kidney disease not on dialysis and on dialysis.
Finerenone (Kerendia) Gets FDA Nod for Chronic Kidney Disease in Type 2 Diabetes
July 13, 2021
With approval on July 9, finerenone became the first nonsteroidal mineralocorticoid receptor antagonist approved by the FDA for treatment of chronic kidney disease associated with type 2 diabetes.
Renewed Hope for Inclisiran as Novartis Announces Complete Response Resubmission to US FDA
July 08, 2021
Novartis announced the Complete Response resubmission for inclisiran in a statement on July 6, 2021.
Dabigatran Etexilate (Pradaxa) Becomes First Oral Blood-Thinning Option for Use In Pediatric Patients
June 21, 2021
The FDA has granted approval to dabigatran etexilate (Pradaxa) for treatment of blood clots in pediatric patients with VTE and prevention of recurrent blood clots in those who have completed treatment for VTE.
Medtronic Halts Sale of HVAD System, FDA Issues Warning to Stop New Implants
June 04, 2021
After receiving more than 100 complaints, including some involving death, Medtronic has halted sale of the HeartWare Ventricular Assist Device System and the FDA has issued a warning to clinicians to stop new implants of the device.
Rosuvastatin/Ezetimibe Combination Therapy Approved for Lowering LDL-C
April 05, 2021
Althera Pharmaceuticals announced the FDA approved rosuvastatin and ezetimibe (Roszet) as an adjunct to diet for lowering LDL-C in adults patients with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia.
FDA Approves Alirocumab (Praluent) as Add-On for Homozygous Familial Hypercholesterolemia
April 02, 2021
Announced in a statement by the FDA on April 1, the PCKS9 inhibitor alirocumab is now indicated as an add-on therapy for the treatment of homozygous familial hypercholesterolemia.
Medtronic's Harmony TPV System Receives Historic FDA Approval for Congenital Heart Disease
March 26, 2021
The FDA announced approval for the Harmony Transcatheter Pulmonary Valve device for treatment of patients with native or surgically-repaired right ventricular outflow tract was awarded to Medtronic Inc.
FDA Expands Label for Sacubitril/Valsartan (Entresto) to Include Some HFpEF Patients
February 16, 2021
Novartis announced the US FDA has expanded the label for sacubitril/valsartan (Entresto) to include reducing the risk of CV death and hospitalizations for heart failure among patients with chronic heart failure.