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Ferring, Blackstone invest $570m in nadofaragene firadenovec gene therapy

Ferring Pharmaceuticals, a Swiss specialty biopharmaceutical group, has teamed up with private investment platform Blackstone Life Sciences to jointly invest more than $570 million in nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy. Currently, nadofaragene firadenovec is in late-stage development for the treatment of patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). […]

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Usona Institute gets FDA breakthrough status for psilocybin in MDD

Wisconsin-based Usona Institute has been granted breakthrough therapy designation for psilocybin from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). According to Usona Institute, the designation secured by psilocybin for major depressive disorder acknowledges the unmet medical need in the broad population and also the potential for significant […]

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SK Biopharmaceuticals bags XCOPRI FDA approval for partial-onset seizures

XCOPRI FDA approval : SK Biopharmaceuticals said that its US subsidiary SK Life Science has been granted approval from the US Food and Drug Administration (FDA) for its anti-epileptic drug XCOPRI (cenobamate tablets) for the treatment for partial-onset seizures in adults. According to the FDA, a seizure is normally a short episode of abnormal electrical activity […]

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Carestream’s digital imaging technologies get FDA approval

Carestream’s Dual Energy imaging technology and also its Focus 35C Detector with Image Suite Software have secured 510 (k) clearance from the US Food and Drug Administration (FDA). Powered by Carestream’s Eclipse image-processing engine, the dual-energy application utilizes a couple of filter materials which are switched automatically between the high- and low-energy exposures. This helps […]

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Levo gets FDA fast track status for LV-101 in Prader-Willi syndrome

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 […]

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Novartis bags Adakveo FDA approval to reduce VOCs in sickle cell disease

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 […]

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F2G gets olorofim breakthrough therapy status from FDA for mold infection

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 […]

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Celgene, Acceleron bag Reblozyl FDA approval for anemia in beta thalassemia

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 […]

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Avrobio gets FDA orphan status for AVR-RD-02 in Gaucher disease

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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Janssen bags Stelara FDA approval for ulcerative colitis treatment

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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