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Reata Pharmaceuticals Announces FDA Approval of SKYCLARYS™ (Omavaloxolone)
Tuesday, February 28, 2023Reata Pharmaceuticals announced that the US Food and Drug Administration FDA has approved SKYCLARYS omaveloxolone for the treatment of Friedreichs ataxia in adults and adolescents aged years and older The approval of SKYCLARYS is the first therapy s...
Regeneron and Sanofi Announce U.S. FDA Approval of Kevzara® (sarilumab)
Tuesday, February 28, 2023Regeneron Pharmaceuticals and Sanofi announced that the US Food and Drug Administration FDA has approved Kevzara sarilumab for the treatment of polymyalgia rheumatica PMR an inflammatory rheumatic disease in adult patients consisting of inadequate re...
TransCode Therapeutics Announces Orphan Drug Designation Status for TTX-MC138
Tuesday, February 28, 2023TransCode Therapeutics announced that it has received Orphan Drug Designation ODD from the US Food and Drug Administration FDA for its lead therapeutic candidate TTXMC in pancreatic cancer TTXMC has the potential to dramatically improve clinical outc...
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®)
Monday, February 27, 2023AbbVie announced that the European Medicines Agencys EMA Committee for Medicinal Products for Human Use CHMP recommended the approval of upadacitinib RINVOQ mg induction dose and mg and mg maintenance doses for the treatment of adult patients with...
Singleron Biotechnologies and Macrogen Europe Announce a Strategic Alliance
Monday, February 27, 2023Singleron Biotechnologies and Macrogen Europe announced partnership With this collaboration Singleron Biotechnologies and Macrogen Europe will combine their strengths to provide firstclass single cell multiomics sequencing solutions Together this int...
Azenta Launches Cryo Store Pico™, A Novel Automated Cryogenic Storage System
Monday, February 27, 2023Azenta announced the launch of the Cryo Store Pico Pico a novel automated cryogenic storage system designed for highvalue biological samples used in the many stages of life sciences from discovery to clinical use Pico is an extension of the innovativ...
Lantern Pharma and TTC Oncology Establish AI Collaboration
Monday, February 27, 2023Lantern Pharma announced that it has entered into a research and development collaboration with TTC Oncology The collaboration will focus on leveraging RADR AI insights to advance TTC Oncologys first and bestinclass drug candidate TTC for recurrent E...
Rhythm Pharmaceuticals Announces Acquisition of Xinvento B.V.
Monday, February 27, 2023Rhythm Pharmaceuticals announced that Rhythms Netherlands subsidiary Rhythm Pharmaceuticals Netherlands BV Rhythm BV acquired Xinvento BV This opportunity will expand the pipeline into CHI a rare disease that is well aligned with corporate strategy t...
Ocugen, Inc. Announces U.S. FDA Submission of Investigational New Drug Application
Monday, February 27, 2023Ocugen announced that it has submitted an Investigational New Drug application IND with the US Food and Drug Administration FDA to initiate a Phase clinical trial of OCU a fusion protein with a distinct mechanism of action MOA for the treatment of d...
FDA Approves Once-Weekly ALTUVIIIO™, a New Class of Factor VIII Therapy
Thursday, February 23, 2023The US Food and Drug Administration FDA has approved ALTUVIIIO Antihemophilic Factor Recombinant FcVWFXTEN Fusion Proteinehtl previously referred to as efanesoctocog alfa a firstinclass highsustained factor VIII replacement therapy ALTUVIIIO is indic...
