Tuesday, December 10, 2019

Tuesday, December 10, 2019

Latest News

U.S. FDA: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device.

U.S. FDA: FDA approves novel treatment to target abnormality in sickle cell disease

The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.

U.S. FDA: Approves first therapy to treat patients with rare blood disorder

Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

TRANSTHERA BIOSCIENCES: Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma

TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.

EIP PHARMA: Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)

Phase 2 clinical trial of neflamapimod in patients with mild-to-moderate DLB currently enrolling patients in the U.S. and the Netherlands

WELLDOC, INC: Welldoc's Award-winning Digital Health Solution BlueStar Adds FDA-Clearance for Use in Type 1 Diabetes

This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes

U.S. FDA: Authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology.

ASTELLAS PHARMA: U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury

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 ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.

SOPHIRIS BIO: Receives Positive Feedback from FDA Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design

Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.

NEUREN: FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes

Neuren Pharmaceuticals (ASX: NEU) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren’s NNZ-2591 for the treatment of Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome.

DAIICHI SANKYO: [Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.

DENOVO BIOPHARMA: Receives FDA's Permission to Proceed with a Biomarker-Guided Phase 2b Clinical Trial with DB102 (Enzastaurin) In First-Line Treatment of Glioblastoma (GBM)

pies, today announced FDA's approval to initiate Denovo's Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation an

OCTAPHARMA USA: FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients

Octapharma USA announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.

FDA Health News