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Press Releases
Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health
March 28, 2025
·
3 min read
C-suite
Stoffels To Depart Galapagos, Short of Five-Year Mission To Remake the Biotech
Paul Stoffels left his perch as J&J’s chief scientific officer in 2022 to replace Galapagos’ founding CEO Onno van de Stolpe, inheriting a company that had suffered a series of clinical failures since its 1999 creation.
April 22, 2025
·
2 min read
·
Annalee Armstrong
Press Releases
Tr1X Announces Succession Plan: Appoints David de Vries CEO, Effective June 1; Bill Lis to Serve as Executive Chairman
March 31, 2025
·
3 min read
Press Releases
Care Access Announces Acquisition of Centro Multidisciplinar de Estudos Clínicos (CEMEC), a Leading Brazil-Based Clinical Research Center
March 10, 2025
·
3 min read
Press Releases
Breakthrough technology for human muscle fatigue measure, Myocene, gets FDA “de novo” approval.
January 30, 2025
·
2 min read
Deals
Servier Nabs Solid Tumor Asset in up to $780M Deal With Black Diamond
The French pharma is getting Black Diamond’s de-prioritized molecule for non-small cell lung cancers with specific mutations whose development had been paused to save money.
March 19, 2025
·
2 min read
·
Dan Samorodnitsky
Press Releases
FDA Grants De Novo Marketing Authorization for the Distalmotion Dexter® Surgical Robot
October 28, 2024
·
5 min read
Press Releases
LifeMine Announces First Participant Dosed in First-in-human Phase 1 Clinical Trial of LIFE-001, Designed De Novo to Become a Field Dominating Immunosuppressive for Immune-mediated Disorders and Transplantation
April 8, 2025
·
4 min read
Business
Echosens Appoints Dr. Victor De Lédinghen as Chief Medical Officer
Echosens announced the appointment of Victor de Lédinghen, MD PhD, as the company’s new Chief Medical Officer.
March 26, 2024
·
2 min read
BioCapital
MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants
MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the U.S. Food and Drug Administration’s (FDA) De Novo granting for Onkos Surgical’s antibacterial coating for tumor and revision orthopedic implants.
June 20, 2024
·
4 min read
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