DALLAS, Texas — Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for inherited retinal diseases and age-related macular degenerations (AMD), today provided an update following recent regulatory discussions with the U.S. Food and Drug Administration (FDA) and from the Scientific Advice meeting with the Icelandic Medicines Agency (IMA),...
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Tokyo, Japan – Cancer has a high death rate with delayed diagnosis of the disease being one of the main reasons for its fatality. Early diagnosis of cancer is vital to improving patient outcomes and in recent years, the development of diagnostic tools to detect early-stage cancer has gained a...
SAN FRANCISCO, CA – Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the company’s ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo’s Scientific...
SAN FRANCISCO, CA – Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel crofelemer powder for oral solution for use in two expanded access programs, authorized by the U.S. Food and Drug Administration (FDA), to treat pediatric intestinal failure patients with microvillus inclusion disease (MVID). “Napo...
Philadelphia, PA – Thursday afternoon marked a major regulatory milestone. In one of the year’s most highly anticipated FDA decisions, the regulator approved Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) as the first-ever therapy for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH). Or was the approval for metabolic dysfunction-associated steatohepatitis (MASH)? If...
AUSTIN, Texas — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology – Precision Oncology (JCO PO). The paper features results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker for patients...
DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the National Comprehensive Cancer Network® (NCCN) added Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (ALL), for both pediatric and adult patients. The NCCN Guidelines for ALL and the NCCN Guidelines for Pediatric...
Bethesda, Maryland – Scientists at the National Institutes of Health (NIH) and their colleagues have identified a gene responsible for some inherited retinal diseases (IRDs), which are a group of disorders that damage the eye’s light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each...
OXFORD, England – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Sunosi®▼ (solriamfetol) for adults with excessive daytime sleepiness (EDS) caused by narcolepsy.[1] Solriamfetol is recommended as an option for treating EDS in...
North Bethesda, Maryland – Studies of interactions between two lab-generated monoclonal antibodies (mAbs) and an essential Epstein-Barr virus (EBV) protein have uncovered targets that could be exploited in designing treatments and vaccines for this extremely common virus. The research was led by Jeffrey I. Cohen, M.D., and colleagues from the...