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Celgene bags Inrebic FDA approval for myelofibrosis

Inrebic FDA approval : Celgene’s subsidiary Impact Biomedicines, has bagged approval for its oral kinase inhibitor Inrebic (fedratinib) capsules from the US Food and Drug Administration (FDA) for the treatment of certain types of myelofibrosis, a rare bone marrow cancer. Fedratinib FDA approval is for the treatment of adult patients with intermediate-2 or high-risk primary […]

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AbbVie secures Rinvoq FDA approval for rheumatoid arthritis

Rinvoq FDA approval : US biopharma company AbbVie has bagged approval from the US Food and Drug Administration (FDA) for its 15mg, daily once oral, small molecule Janus kinase (JAK) inhibitor – Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis (RA). The FDA approval for Rinvoq is for the treatment of […]

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FDA approves CVRx Barostim Neo System for advanced heart failure symptoms

CVRx, a Maple Grove-based medical device company, has secured approval for its implantable technology – Barostim Neo System from the US Food and Drug Administration (FDA) to improve symptoms in patients with advanced heart failure. As per the FDA approval for the CVRx Barostim Neo System, the medical device has to be used in patients […]

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Neuropore gets FDA orphan drug designation for NPT520-34 for ALS

Neuropore Therapies has secured orphan drug designation for NPT520-34 from the US Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). The California-based biopharma company said that the orphan drug designation will enable the development of NPT520-34 in the treatment of the debilitating medical condition for which there are not many […]

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NinePoint’s NvisionVLE Imaging System cleared for pancreatic and biliary applications

The US Food and Drug Administration (FDA) has cleared transformative medical device company NinePoint Medical to market NvisionVLE Imaging System for pancreas and bile duct applications, in addition to the previously existing esophageal use. The Optical Coherence Tomography (OCT) imaging platform, NvisionVLE Imaging System, will help gastroenterologists to thoroughly evaluate tissue for regions of interest […]

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