Milestone Achievement Reflects First Investigational Candidate to Emerge Under Multi-Target Collaboration and Triggers $10 Million Payment to Dicerna
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment
Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus’ artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform.
SimpleSENSE provides a continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system without the need for an in-person doctor's visit
Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced its clinical partner- Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II investigator-initiated trial (IIT) evaluating Silmitasertib, a novel orally available casein
Quansys Biosciences announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based IgG antibody test.
Bioelectronics solution addresses drug-refractory chronic migraine
CNS to Discuss Potentially Pivotal Phase 2 Trial for Berubicin in Webcast on November 12th; Adaptive Trial Design May Open Opportunity for Expedited Pathway for Development and/or Approval
The U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD).
Senhwa Biosicences, Inc. issued the following announcement on Nov. 2.Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced that it has submitted an Investigational New Drug (IND) application with the U.S.
The U.S. Food & Drug Administration (FDA), Silver Spring / Maryland, has granted Syntellix's MAGNEZIX® CS 3.2 device and proposed indication for use the designation of a "Breakthrough Device".
First next-generation DNA vaccine candidate to deliver spike (S) protein from SARS-CoV-2 plus immune-stimulating interleukin-12 (IL-12) to elicit T-cell activation and drive robust humoral immunity
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.
Cognita Labs issued the following announcement on Oct. 28.Cognita Labs, a leading respiratory technologies company, today announced that the U.S.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) announced today that the United States ("U.S.") Food and Drug Administration (FDA) has granted Fast Track designation based on nonclinical and clinical data for the development of ASP5354, an imaging agent being investigated for intraoperative ureter visualization in patients undergoing minimally invasive and open abdominopelvic surgeries.
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 ("ASP0367") as a potential treatment for primary mitochondrial myopathies (PMM).