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Home » Posts tagged with » US Food and Drug Administration
Eiger bags FDA breakthrough therapy status for HDV drug candidate Lambda

Eiger bags FDA breakthrough therapy status for HDV drug candidate Lambda

US biopharma company Eiger BioPharmaceuticals said that peginterferon lambda (Lambda) has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of hepatitis delta virus (HDV) infection. Breakthrough therapy designation enables expedition of the development and review of drugs intended for the treatment of a serious condition and where […]

Nabriva secures Xenleta FDA approval for community-acquired pneumonia

Xenleta FDA approval : Irish pharma company Nabriva Therapeutics has bagged approval from the US Food and Drug Administration for its semi-synthetic pleuromutilin antibiotic Xenleta (lefamulin) for the treatment of community-acquired bacterial pneumonia in adults. Community-acquired pneumonia is caused when someone develops pneumonia in the community, that is not in a hospital. Pneumonia is a […]

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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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Dynacure’s centronuclear myopathies drug DYN101 gets FDA orphan drug designation

French pharma company Dynacure has secured orphan drug designation for its investigational antisense drug DYN101 from the US Food and Drug Administration (FDA) for the treatment of Centronuclear Myopathies (CNM). DYN101, which is designed to modulate the expression of dynamin 2 (DNM2), will undergo its first human clinical trial in the form of the Unite-CNM […]

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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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Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome

US biotech company Stoke Therapeutics has secured orphan drug designation for its lead product candidate – STK-001 from the US Food and Drug Administration (FDA) for the treatment for Dravet syndrome. Considered to be a severe and progressive genetic epilepsy, Dravet syndrome is characterized by frequent, prolonged and refractory seizures that start within the first […]

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Foamix files NDA seeking FMX103 FDA approval for rosacea

Israeli pharma company Foamix Pharmaceuticals has filed a new drug application (NDA) for FMX103 to the US Food and Drug Administration (FDA) seeking FMX103 FDA approval for moderate-to-severe papulopustular rosacea in patients, aged 18 years and over. Considered to be a common skin condition, rosacea results in redness and visible blood vessels in the face. […]

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