Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. 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.

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

The Pharma Data

FEBRUARY 24, 2022

Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. The FDA granted the approval of Jardiance to Boehringer Ingelheim.

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FDA Approval Cosmetics Cardiology Production 52

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 mL subcutaneous solution (2 mg/1.5 billion in Q4 2022.

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Sales Insulin FDA Approval Drugs 52

FDA Law Blog

FEBRUARY 21, 2022

Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). While at FDA, Dr. Unger’s Office oversaw the approval and regulation of scores of new drugs for cardiovascular, renal, neurological, and psychiatric disorders.

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Drugs Cardiology FDA Approval Doctors 40

XTalks

JUNE 11, 2024

The US Food and Drug Administration (FDA) recently approved Boston Scientific’s Agent drug-coated balloon (DCB) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease (CAD). Many companies have already developed their own DCBs, each with unique features supported by varying levels of clinical evidence.

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Drugs Drug Delivery Cardiology Marketing 52

pharmaphorum

JUNE 22, 2021

The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.

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Sales Marketing FDA Approval Regulation 98

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc. billion.

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