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Advanced NanoTherapies’ SirPlux Duo Drug-Coated Balloon Receives FDA Breakthrough Designation…

Sep 20, 2022
Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease's most significant challenges through the creative applications of…
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Repligen Expands Process Analytics Portfolio with DRS Daylight Solutions Agreement

Sep 20, 2022
Repligen Corporation announced it has entered into a strategic partnership and exclusive license agreement with DRS Daylight Solutions to expand the use of mid-infrared (mid-IR)…
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NICE Recommends BeiGene’s BRUKINSA (zanubrutinib) for Patients with Waldenström’s Macroglobulinemia…

Sep 20, 2022
BeiGene announced that England’s health technology assessment institute, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal document (FAD)…
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GENFIT to Acquire Clinical-stage Biopharmaceutical Company Versantis, expanding its Portfolio in…

Sep 20, 2022
GENFIT,  a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, announced it has entered into an exclusivity agreement…
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European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two…

Sep 20, 2022
Roche announced that the European Commission (EC) approved Vabysmo (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment…
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Conference Co-Chairs Invite Medical Devices Experts to the Medical Devices & IVD Conference

Sep 19, 2022
SAE Media Group: Blake Green, Director Regulatory Affairs, Amgen and Anne Whalen, Previous Director, Novartis invite experts to join for the Medical Devices & IVD Conference SAE…
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Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of…

Sep 19, 2022
Recommendation based on TACKLE Phase III treatment data showing reduced risk of severe COVID-19 or death AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly…
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bluebird bio Receives FDA Accelerated Approval for SKYSONA Gene Therapy for Early, Active Cerebral…

Sep 19, 2022
bluebird bio, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of SKYSONA (elivaldogene autotemcel), also known as eli-cel, to slow the…
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Bristol Myers Squibb Receives European Commission Approval for LAG-3-Blocking Antibody Combination,…

Sep 19, 2022
Bristol Myers Squibb announced that the European Commission (EC) has approved the fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced…
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NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration to License and…

Sep 16, 2022
NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co., Ltd. announced that they have entered into a conditional exclusive license agreement for NeuroBo to develop and commercialize DA-1241…
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