US biotech company Levo Therapeutics has been granted fast track designation for LV-101 (intranasal carbetocin) from the US Food and Drug Administration (FDA) for the treatment of Prader-Willi syndrome (PWS). According to the US National Library of Medicine, Prader-Willi syndrome is a complex genetic condition that impacts several parts of the body. In infancy, Prader-Willi […]
Continue reading …Novartis bags Adakveo FDA approval to reduce VOCs in sickle cell disease
November 16, 2019 No Comment
Adakveo FDA approval : Swiss drugmaker Novartis has bagged approval for Adakveo (crizanlizumab-tmca) from the US Food and Drug Administration (FDA) for its use in sickle cell disease. Formerly known as SEG101, Adakveo has been indicated to be used for bringing down the frequency of vaso-occlusive crises (VOCs), or pain crises, in patients, aged 16 […]
Continue reading …F2G gets olorofim breakthrough therapy status from FDA for mold infection
November 12, 2019 No Comment
F2G has secured breakthrough therapy designation to olorofim (formerly F901318) from the US Food and Drug Administration (FDA) for the treatment of invasive mold infections. The breakthrough therapy designation is for the use of olorofim in patients having limited or no treatment options, and also those who are intolerant to currently available therapy for their […]
Continue reading …Celgene, Acceleron bag Reblozyl FDA approval for anemia in beta thalassemia
November 9, 2019 No Comment
Reblozyl FDA approval : Celgene and Acceleron Pharma have bagged approval from the US Food and Drug Administration (FDA) for Reblozyl (luspatercept-aamt) for the treatment of anemia associated with beta thalassemia in adults who need regular red blood cell (RBC) transfusions. Reblozyl is now the first and only erythroid maturation agent to be approved by […]
Continue reading …Mirum gets FDA breakthrough therapy status for maralixibat for Alagille syndrome
October 29, 2019 No Comment
Mirum Pharmaceuticals has secured the breakthrough therapy designation for maralixibat from the US Food and Drug Administration (FDA) for the treatment of pruritus associated with Alagille syndrome (ALGS) in patients, aged 1 year and older. The California-based biopharma company is engaged in the development and commercialization of new therapies for debilitating liver diseases. Alagille syndrome […]
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US gene therapy company Avrobio has secured orphan-drug designation for AVR-RD-02, its investigational gene therapy, for the treatment of Gaucher disease, from the US Food and Drug Administration (FDA). AVR-RD-02 is made up of the patient’s own hematopoietic stem cells, which are modified genetically to express glucocerebrosidase (GCase), an enzyme that is deficient in Gaucher […]
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Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged approval from the US Food and Drug Administration (FDA) for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis. Considered to be a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, […]
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Ultomiris FDA approval : Alexion Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for Ultomiris (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) in adults and pediatric (one month of age and older) patients. The approval is for the prevention of complement-mediated thrombotic microangiopathy (TMA) in such patient populations. […]
Continue reading …Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne
October 20, 2019 No Comment
AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for AMZEEQ (minocycline) topical foam, 4% for the treatment of moderate to severe acne. Previously known as FMX101, AMZEEQ has been indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne […]
Continue reading …Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients
October 18, 2019 No Comment
Xarelto FDA approval : The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) for the prevention of venous thromboembolism or blood clots in acutely ill medical patients. The latest approval for the drug is for the treatment of blood clots in hospitalized […]
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