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CooperVision MiSight contact lens gets FDA approval to slow down myopia in children

CooperVision MiSight contact lens gets FDA approval to slow down myopia in children

Soft contact lens manufacturer CooperVision has secured approval for its MiSight contact lens from the US Food and Drug Administration (FDA) to slow the progression of myopia (nearsightedness) in children aged between 8 and 12 years old at the initiation of treatment. Manufactured as a single use, disposable, soft contact lens, the MiSight contact lens […]

Novartis bags Beovu FDA approval for wet AMD

Beovu FDA approval for wet AMD : Swiss pharma giant Novartis has been given approval from the US Food and Drug Administration (FDA) for Beovu (brolucizumab) injection for wet age-related macular degeneration (AMD). Also called RTH258, Beovu is now the first FDA approved anti-VEGF which is said to deliver greater fluid resolution compared to aflibercept. […]

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ProTom Radiance 330 proton therapy system bags FDA 510(k) Clearance

ProTom International has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiance 330 proton therapy system installed at the Massachusetts General Hospital (MGH) in Boston. According to the proton therapy technology manufacturer, the installed Radiance 330 proton therapy system is a compact, single-room system, which features an advanced pencil […]

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Annexon gets FDA fast track status for ANX005 in Guillain-Barré Syndrome

Annexon Biosciences has bagged the fast track designation for its C1q inhibitor ANX005 from the US Food and Drug Administration (FDA) for the treatment of Guillain-Barré Syndrome (GBS). Considered to be a rare, acute, antibody-mediated autoimmune disease, Guillain-Barré Syndrome affects the peripheral nervous system for which there are no approved therapies in the US till […]

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Genentech bags Rozlytrek FDA approval for two rare types of cancer

Rozlytrek FDA approval : Roche’s subsidiary Genentech has bagged approvals for Rozlytrek (entrectinib) from the US Food and Drug Administration (FDA) for a type of non-small cell lung cancer (NSCLC) and for certain forms of solid tumors. The first Rozlytrek FDA approval is for the treatment of ROS1-positive, metastatic NSCLC in adult patients. Additionally, Rozlytrek […]

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Lilly bags Taltz FDA approval for ankylosing spondylitis

Taltz FDA approval : The US Food and Drug Administration (FDA) has approved US pharma giant Eli Lilly and Company’s Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults having active ankylosing spondylitis (AS). Also known as radiographic axial spondyloarthritis (r-axSpA), ankylosing spondylitis is a type of spondyloarthritis that affects the pelvic joints and […]

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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 […]

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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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