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Veristat Congratulates Origin Biosciences for FDA Approval

Veristat Congratulates Origin Biosciences for FDA Approval of Nulibry during the Week of Rare Disease Day 2021


Veristat Supported the NDA and Celebrates this Milestone Achievement for Children and their Families Fighting This Rare Disease



SOUTHBOROUGH, MA – 8 March 2021 –Veristat, a scientific-minded, global clinical research organization (CRO), today congratulated Origin Biosciences for their FDA approval of Nulibry (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. This rare disease product received FDA approval on Friday, 26 February 2021, during the week when the world celebrated #RareDiseaseDay2021.

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Veristat Supported Marketing Applications for 10% of all FDA Novel Drug Approvals in 2020

Strengthening its Track Record of Successful Client Regulatory Approval Outcomes

SOUTHBOROUGH, MA – January 14, 2021 – Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)[i], and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe.

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Veristat Announces Global Cell and Gene Therapy Center of Excellence

Accelerating cell and gene therapy opportunities for patients by advancing access to knowledge and leveraging experience for sponsors to increase program success

SOUTHBOROUGH, MA – October 22, 2020 – Cell and gene therapies represent the next great wave of therapeutic innovation and have led to the development of promising therapies worldwide.

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Veristat Strengthens Its European Presence with the Acquisition of TCTC

Increasing Its Footprint and Expanding Therapeutic Expertise to Guide Sponsors Throughout the Clinical Development Lifecycle

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Veristat Strengthens Its Regulatory Expertise with the Acquisition of Catalyst Regulatory Services

Expanding Its Team of Regulatory Experts to Guide Biopharmaceutical Sponsors
 Along the Pathway to Market Approval

 

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Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals

Veristat Celebrates Its Support of over 75 Global Regulatory Submissions Since Its Founding

 

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Veristat Strengthens Clinical Operations Capabilities - Acquires Topstone Research

Expanding Its Clinical Operations and Biometrics Teams Dedicated to Emerging, Small and Mid-Sized Biopharma

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Veristat Congratulates Alnylam on the FDA Approval of ONPATTRO™

Continues Collaboration to Provide Regulatory Submission Support for
Additional Patisiran Submissions

 

SOUTHBOROUGH, MA –  August 20, 2018 –   Veristat, a full service Clinical Research Organization (CRO), congratulates Alnylam on the recent FDA approval of ONPATTRO™ (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 

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Veristat Congratulates Agios on the FDA Approval of TIBSOVO®

 The First Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation

 

SOUTHBOROUGH, MA –  August 16, 2018 –   Veristat, a full service Clinical Research Organization (CRO), congratulates Agios on the recent FDA approval of TIBSOVO® (ivosidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test.

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Veristat is Recognized on the Inc. 5000 List of America’s Fastest-Growing Private Companies for the 4th Consecutive Year

 Veristat’s Continued Innovation of Its Clinical Development Strategies and Services Allow the Company to Execute High Quality Trials That Reach Regulatory Approval

 

SOUTHBOROUGH, MA –  August 15, 2018 –   Veristat, a full service Clinical Research Organization (CRO), proudly announces its recognition once again by Inc. Magazine as one of the 5000 fastest-growing private companies in the United States. 

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