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Amicus Therapeutics Announces FDA Approval and Launch of New Treatment for Pompe Disease

Oct 2, 2023
Amicus Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules. This…
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Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large…

Oct 2, 2023
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to…
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MilliporeSigma to Become First Provider to Offer Fully Integrated mRNA Services

Sep 27, 2023
MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, is the first CTDMO (contract testing, development and manufacturing organization) to offer…
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Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for…

Sep 27, 2023
Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko…
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Acesion Pharma Closes Oversubscribed €45M Series B Financing Round to Advance Development of Novel…

Sep 27, 2023
Acesion Pharma announces that it has successfully closed an oversubscribed €45M Series B financing round. The equity financing was co-led by new US-based investors Canaan and Alpha Wave…
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Arcturus Therapeutics and Cystic Fibrosis Foundation Extend Agreement to Advance ARCT-032, an…

Sep 27, 2023
Arcturus Therapeutics Holdings Inc., a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within…
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Extractables and Leachables Europe 2023 set to feature leading industry experts

Sep 26, 2023
"The conference is the place to be for the E&L community!" - Senior Business Development Manager, Agilent Technologies Now in its 17th year, E&L Europe is set to take place…
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Extractables and leachables Europe 2023 – Interactions of E&L

Sep 26, 2023
E&L examination is continuously growing in importance and given the current scrutiny paid by governing bodies including the FDA and MHRA, understanding the best practice and…
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Extractables and Leachables Europe 2023 medical devices focus

Sep 26, 2023
Now in its 17th year, E&L Europe is set to take place on 6-7 November in Amsterdam and once again will feature leading industry experts covering the most pertinent topics impacting…
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Japan’s Ministry of Health, Labour and Welfare approves GSK’s Arexvy, the country’s first…

Sep 26, 2023
GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV…
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Industry Reports

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Press Releases

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