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FDA Approves First Treatment for Adult Onset Still’s Disease
americanpharmaceuticalreview
June 28, 2020
The U.S. Food and Drug Administration (FDA) approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD).
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FDA grants fast track status to NeuroRx’s Covid-19 drug candidate
pharmaceutical-technology
June 28, 2020
The US Food and Drug Administration (FDA) has granted fast track designation to RLF-100 (Aviptadil), which is being developed by NeuroRx and Relief Therapeutics to treat acute lung injury / acute respiratory distress syndrome caused by Covid-19.
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US FDA grants approval of Fintepla to Zogenix
expresspharma
June 28, 2020
Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome: Zogenix.
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FDA Grants Breakthrough Device Designation to Thermo Fisher’s Oncomine Precision Assay
americanpharmaceuticalreview
June 24, 2020
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay.
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GSK recalls three lots of children’s cough medicine in US
europeanpharmaceuticalreview
June 24, 2020
GlaxoSmithKline has voluntarily recalled two lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough in the US.
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FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord
americanpharmaceuticalreview
June 23, 2020
The U.S. Food and Drug Administration (FDA) approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody.
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Alembic Pharma gets tentative US FDA nod for generic Rivaroxaban tablets
expresspharma
June 23, 2020
The tablet is the generic of Janssen Pharmaceuticals's reference listed drug product Xarelto.
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Novartis gets FDA approval for Cosentyx to treat active non-radiographic axial spondyloarthritis
pharmaceutical-business-review
June 22, 2020
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Cosentyx (secukinumab) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).
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FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19
americanpharmaceuticalreview
June 22, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Illumina, for the first COVID-19 diagnostic test utilizing next generation sequence technology.
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Epizyme’s Tazverik secures FDA approval to treat follicular lymphoma
pharmaceutical-technology
June 22, 2020
Epizyme has secured accelerated approval from the US Food and Drug Administration (FDA) for Tazverik to treat relapsed / refractory follicular lymphoma.