Industry Dynamics

Industry News

08-31

2020

FDA approves Novartis Kesimpta? (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

August 20, 2020 ― Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta? (ofatumumab, formerly OMB257) as an injection for subcutaneous use for the treatment of relapsing forms of ……

08-03

2020

MYR Pharmaceuticals receives Conditional Marketing Authorization by the European Commission for HEPCLUDEX?

Aug. 4, 2020 -- MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that the Europea……

07-28

2020

European Commission approves third nintedanib indication in pulmonary fibrosis

July25, 2020 ? Boehringer Ingelheim today announced that the European Commission (EC) has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases……

07-10

2020

Novartis receives EC approval for Enerzair? Breezhaler?, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU

July 7, 2020 ― Novartis today announced that the European Commission (EC) has approved Enerzair? Breezhaler? (QVM249; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) as a maintenance trea……

06-29

2020

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

June 28, 2020-- Today, the U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by……

06-05

2020

BRILINTA Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease

June 02, 2020 - AstraZeneca’s BRILINTA? (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of hear……

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