Remove Cardiology Remove Clinical Trials Remove FDA Approval
article thumbnail

Abbott’s New Leadless Pacemaker Receives FDA Approval for Slow Heart Rhythms

XTalks

Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. The Illinois-based company received the FDA nod for its new pacemaker to treat patients with bradycardia (slow heart rhythms).

article thumbnail

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Tryngolza (Olezarsen) Becomes First FDA-Approved Drug for Familial Chylomicronemia Syndrome

XTalks

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. In clinical trials, it showed up to an 86 percent reduction in triglyceride levels. Investigational drug plozasiran , developed by Arrowhead Pharmaceuticals, is under review for FCS treatment.

article thumbnail

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

The Pharma Data

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

article thumbnail

Etripamil Nasal Spray Shows Promising Phase III Results for PSVT Treatment

XTalks

a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). It received FDA approval in 1998.

article thumbnail

Cleveland Clinic led trial shows drug effective in 96% of patients with recurrent pericarditis

Scienmag

ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinical trial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of […].

Trials 41
article thumbnail

Nevro’s Spinal Cord Stimulation; Boston’s PINNACLE FLX; NuVasive’s Modulus ALIF; J&J’s VERITAS Vision System; Medtronic’s DCB Catheter; AngelMed’s Heart Attack Warning System

Delveinsight

Nevro Received FDA Approval of its 10 kHz High-Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy. received approval for its Senza System, Nevro’s unique 10 kHz stimulation, to treat chronic pain associated with Painful Diabetic Neuropathy (PDN).