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FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor

Amgen announced that the U.S. FDA has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1 The Pushtronex system is a hands-free device designed to provide 420 mg...

EMA accepts Merck’s MAA for cladribine tablets in multiple sclerosis

Merck, a leading science and technology company announced that the EMA to request the company for marketing approval for its investigational Cladribine Tablets for the treatment of relapsing multiple sclerosis (MS) to adopted examination. "Our marketing...

Biogen SB5 accepted for review by European Medicines Agency

The Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the EMA. The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung...

Abbott laboratories says U.S. FDA approves tecnis symfony intraocular lenses

Approval includes toric version of symfony iol for people with astigmatism lenses provide high-quality continuous vision so patients can see clearly at near, intermediate and far-away distances, and points in between, while wearing glasses less ...

Regeneron and Sanofi announce approval of praluent (alirocumab) in Japan

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Praluent® (alirocumab) for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol, in certain adult patients with...

Boehringer Ingelheim and University of Dundee collaborate to develop new class of medicines

Collaboration aims to develop PROteolysis TArgeting Chimeric molecules (PROTACs) – a new therapeutic modality that is able to degrade proteins playing a central role in disease processes PROTACs and their new mechanism of action are expected to open...

Health Canada approves Abbott’s Absorb Bioresorbable Stent

Revolutionary Device Made Of Naturally Dissolving Material, Similar To Dissolving Sutures Treats Coronary Artery Disease Like A Metallic Stent, But Then Disappears After The Artery Is Healed, Leaving No Metal Behind To Restrict Natural Vessel Motion....

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