AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis

1 June 2020 - Submissions supported by two Phase 3 studies in which Rinvoq demonstrated improved joint outcomes, physical function and ...

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Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease

1 June 2020 - New Brilinta indication expands treatment to high-risk coronary patients without a history of stroke or heart ...

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CytoDyn files request with FDA for priority review of BLA for first approval

1 June 2020 - If granted, the FDA is expected to take action on the Company’s BLA within six months. ...

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Lilly's Taltz (ixekizumab) is the first IL-17A antagonist to receive U.S. FDA approval for the treatment of non-radiographic axial spondyloarthritis

1 June 2020 - Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis, also known ...

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Zionexa USA and PETNET Solutions announce FDA approval of Cerianna (Fluoroestradiol F 18)

27 May 2020 - Zionexa USA and PETNET Solutions have announced that the FDA has approved Cerianna (fluoroestradiol F 18) injection ...

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U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis

27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...

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Orphazyme initiates rolling submission of new drug application for arimoclomol with US FDA in Niemann-Pick disease type C

29 May 2020 - EMA marketing authorisation application submission expected in H2 2020. ...

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Menlo Therapeutics receives FDA approval of Zilxi (minocycline) 1.5 % topical foam, the first topical minocycline treatment for rosacea

29 May 2020 - Zilxi now approved for inflammatory lesions of rosacea in adults. ...

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Pharmacist claiming of paracetamol 500 mg with codeine 30 mg tablet prescriptions from 1 June 2020

1 June 2020 - Commencing 1 June 2020, the Pharmaceutical Benefits Scheme listings for opioid medicines will change. Included in ...

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FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program. ...

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FDA approves the first oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women

29 May 2020 - Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is expected to be available in the U.S. ...

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Lilly's Cyramza (ramucirumab) receives FDA approval as first-line treatment for metastatic EGFR mutated non-small cell lung cancer

29 May 2020 - Cyramza, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell ...

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FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease

28 May 2020 - Today, the U.S. FDA approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help ...

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FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim

27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license ...

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Fauci warns about hydroxychloroquine

27 May 2020 - Top administration expert airs differences with Trump on pandemic response. ...

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