XACT Robotics has received US Food and Drug Administration (FDA) clearance for a modification to its XACT ACE ® Robotic System, which is designed to support robotic insertion and steering of ablation probes during ablation clinical procedures. This clearance expands...
Teva Pharmaceutical Industries Ltd welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a license for Ongavia®, a biosimilar to Lucentis® (ranibizumab ), an eye injection. The United Kingdom is the first country in Europe to authorize...
Travere Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN). The FDA has...
Inmagene Biopharmaceuticals announce that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor, to proceed...
Oxford Nanopore sequencing technology is to be used by a group of researchers led by Evan Eichler, University of Washington and Danny Miller, University of Washington and Seattle Children’s Hospital, to initially sequence 500 of the 1000 Genomes Project samples....
Known as a pioneer in Asia’s women’s and fetal health industry, Singapore-based diagnostics developer, INEX Innovate has obtained a CE mark for its lead ovarian cancer product, the OvaCis® Rapid Test. Slated to launch in the EU and Southeast Asian markets...
Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or...
Clario, a technology company that delivers the leading endpoint solutions for decentralized (DCT), hybrid and site-based clinical trials, announced that it has released its first Environmental, Social and Governance (ESG) Report. The report highlights the progress...
Royal Philips, a global leader in health technology, announced it has received FDA 510(k) clearance for the company’s new MR 7700 3.0T MR system. This latest break-through MR innovation from Philips delivers unmatched performance and precision for both research and...
Myovant Sciences and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for MYFEMBREE® for the management of moderate to severe pain associated with endometriosis. The...
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