Remove Cardiology Remove Clinical Trials Remove FDA Approval Remove Trials
article thumbnail

AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

article thumbnail

Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations

XTalks

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Surmodics and Abbott’s Drug-Coated Balloon for Peripheral Artery Disease Gets FDA Approval

XTalks

Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics, in the company’s press release. “It SurVeil has an edge over IN.PACT as it is coated with a lower dose of the drug.

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

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

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

First drug for severe frostbite helps prevent amputation

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Eicos Sciences’ Aurlumyn (iloprost) injection, the first FDA-approved medication to treat severe frostbite. Iloprost’s efficacy in treating severe frostbite was established in an open-label, controlled trial that randomised 47 adults with severe frostbite.

Drugs 52