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GSK’s regulatory submission accepted for review by Japanese regulator for use of Nucala…

Sep 4, 2023
GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a…
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AMGEN AND HORIZON THERAPEUTICS PLC RESOLVE FTC LAWSUIT, CLEARING PATH TO CLOSE ACQUISITION

Sep 4, 2023
Amgen and Horizon Therapeutics plc announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This…
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7th IPF Summit: Advancing Insights and Collaboration in Pulmonary Fibrosis Research and Therapeutic…

Aug 31, 2023
See the full summit details here. The 7th IPF Summit, a premier event in the field of pulmonary fibrosis research, is set to take place from September 19 to 21, 2023, in the vibrant…
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Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in…

Aug 31, 2023
Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for…
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Novo Nordisk acquires Embark Biotech, including its lead asset targeting obesity and other…

Aug 30, 2023
Embark Laboratories announced that Novo Nordisk has acquired Embark Biotech, including its lead metabolic program, and has entered a three-year research and development collaboration to…
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Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital…

Aug 30, 2023
Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced that the US FDA has granted priority review…
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Roche’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to…

Aug 30, 2023
Roche announced that Tecentriq SC (atezolizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. It will be provided by the…
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European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular…

Aug 29, 2023
Roche announced today that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical…
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PURIFY’23 – Registration Now Open

Aug 29, 2023
Are you ready to embark on a transformative journey in the world of chromatography purification? Look no further than PURIFY'23 – the most anticipated event of the year for…
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AbbVie Submits Regulatory Applications to FDA and EMA for Risankizumab (SKYRIZI) in Ulcerative…

Aug 28, 2023
AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI,…
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