Clario Announces Significant Progress and Ambitious Targets in Inaugural Environmental, Social and Governance (ESG) Report
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...
Philips receives FDA 510(k) clearance for latest breakthrough high-performance MR 7700 system
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 Provide Update on Supplemental New Drug Application (sNDA) for MYFEMBREE®
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...
ENHERTU® Approved in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
Daiichi Sankyo and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the...
BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Pediatric Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that the China National Medical Products Administration (NMPA) has granted...
Fast Track Designation in Hand, Graphite Bio Guns for Definitive Sickle Cell Cure
San Francisco-based Graphite Bio announced that it has received Fast Track Designation from the U.S. Food and Drug Administration for its investigational therapy GPH101, which is designed to genetically treat sickle cell disease (SCD). Sickle cell disease has a high...
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