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Ipsen confirms FDA grants priority review for New Drug Application for elafibranor for the treatment…

Dec 8, 2023
Ipsen and GENFIT announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral, once-daily dual…
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Solid Biosciences Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Gene Therapy…

Dec 8, 2023
Solid Biosciences Inc., a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, announced that it has received Fast Track Designation from…
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AbelZeta Pharma Announces Agreement with AstraZeneca to Co-Develop a novel Glypican 3 (GPC3) Armored…

Dec 8, 2023
AbelZeta Pharma Inc. (the Company, or AbelZeta), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative cell therapies for cancer,…
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Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with…

Dec 7, 2023
Arvinas, Inc. and Pfizer Inc. announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination…
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2024 Agenda Revealed: 4th Wet AMD & Diabetic Eye Disease Drug Development Summit

Dec 7, 2023
With the recent FDA-approvals of Bayer’s Eylea HD 8mg as a durable long-term treatment for Wet AMD and Genentech’s Vabysmo for Retinal Vein Occlusion (RVO), now is the time to unite…
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AbbVie and BigHat Biosciences Announce Research Collaboration to Leverage Artificial Intelligence…

Dec 7, 2023
AbbVie Inc. and BigHat Biosciences announced a research collaboration to discover and develop next-generation therapeutic antibodies in oncology and neuroscience. Working closely with…
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Bristol Myers Squibb’s Abecma Becomes First CAR T Approved for Use in Earlier Lines of Therapy…

Dec 7, 2023
Bristol-Myers Squibb K.K. announced that the company has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma …
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2024 Agenda Revealed: 2nd Next Generation Ophthalmic Drug Delivery Summit

Dec 6, 2023
With Novartis joining the suprachoroidal race with their novel injector and Genentech's re-designed sustained release formulations showing promise for wet AMD, there has never been a…
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FDA Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in…

Dec 6, 2023
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination…
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FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE…

Dec 6, 2023
ImmunoGen, Inc. announced that the US Food and Drug Administration (FDA) has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated…
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Press Releases

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