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Y-mAbs begins roll-out of BLA of naxitamab to FDA for neuroblastoma

Y-mAbs begins roll-out of BLA of naxitamab to FDA for neuroblastoma

US biopharma company Y-mAbs Therapeutics has submitted the first portions of its biologics license application (BLA) for naxitamab to the US Food and Drug Administration (FDA), seeking the drug’s approval for the treatment of relapsed/refractory high-risk neuroblastoma under the latter’s Rolling Review process. Naxitamab, an anti-GD2 monoclonal antibody, was granted the FDA breakthrough therapy designation […]

FDA approves ApiFix MID-C system for progressive AIS

Israeli medical devices manufacturer ApiFix has bagged approval from the US Food and Drug Administration (FDA) for marketing its minimally invasive deformity correction system (MID-C system) or the treatment of progressive adolescent idiopathic scoliosis (AIS) through a humanitarian device exemption (HDE). Considered to be the most common form of scoliosis, adolescent idiopathic scoliosis impacts 2-3% […]

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FDA clears Biobeat wearable watch and patch for BP measurement

Israeli biotech company Biobeat has secured a 510A clearance from the US Food and Drug Administration (FDA) for its wearable watch and patch for monitoring blood pressure (BP), oxygenation, and heart rate in clinics, hospitals, long term care and at home. The user will have to use one or the other device, while the watch […]

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Global Blood Therapeutics bags Oxbryta FDA approval for sickle cell disease

Oxbryta FDA approval : Global Blood Therapeutics (GBT), a California-based biopharma company, has bagged approval for Oxbryta (voxelotor) tablets from the US Food and Drug Administration (FDA) for sickle cell disease (SCD). The FDA approval of Oxbryta is for the treatment of adults and children, aged 12 years of age and older, who are suffering […]

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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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