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Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for…

Nov 1, 2022
Almirall, S.A. (ALM) announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of…
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Biofrontera Inc. Enters into Agreements to Purchase Options of Biofrontera AG

Nov 1, 2022
Biofrontera Inc. announced it has entered into private exchange agreements with certain holders of options to acquire ordinary shares of Biofrontera AG (the “AG Options”) in exchange…
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Thermo Fisher Scientific to Acquire The Binding Site Group

Nov 1, 2022
Thermo Fisher Scientific Inc. announced that it has entered into a definitive agreement to acquire The Binding Site Group (“The Binding Site”), a global leader in specialty diagnostics,…
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InnoCare Announces First Adolescent Patient Dosed in Clinical Trial of pan-TRK Inhibitor ICP-723 in…

Nov 1, 2022
InnoCare Pharma announced that the first adolescent patient has been dosed in clinical trial with its second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer…
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Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European…

Nov 1, 2022
Karyopharm Therapeutics Inc. and the Menarini Group announced that the European Commission (EC) has granted orphan medicinal product designation for selinexor for the treatment of…
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Intrinsic Medicine and Phoenix Biotech Acquisition Corp. Announce Merger Agreement to Create Public…

Nov 1, 2022
Intrinsic Medicine, Inc. (Intrinsic), a therapeutics company leveraging human milk biology to transform Gut-Brain Axis (GBA) and inflammatory disorders, and Phoenix Biotech Acquisition…
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Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-251 for the Treatment of Duchenne…

Nov 1, 2022
Dyne Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD)…
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Positive topline phase III results show Roche’s Vabysmo improved vision for people living with…

Oct 31, 2022
Roche announced positive topline results from two global phase III studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, Vabysmo (faricimab), in…
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Outlook Therapeutics Announces Acceptance of Biologics License Application by FDA for ONS-5010 as a…

Oct 31, 2022
Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a Biologics License Application (BLA) for ONS-5010 / LYTENAVA…
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AbbVie Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody-CD3xCD20) for the…

Oct 31, 2022
AbbVie announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous…
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