Nasal spray medicine for treatment-resistant depression not recommended by NICE

28 January 2020 - More evidence on the clinical and cost effectiveness of esketamine needed. ...

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Alkermes announces U.S. FDA acceptance of ALKS 3831 new drug application for treatment of schizophrenia and bipolar I disorder

28 January 2020 - Alkermes today announced that the U.S. FDA has accepted for review the company's new drug application ...

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FDA continues strong support of innovation in development of gene therapy products

28 January 2020 - This is a pivotal time in the field of gene therapy as the FDA continues its ...

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It’s the insulin, stupid: how drug pricing’s simplest case study became a top issue for 2020 Democrats

28 January 2020 - Presidential candidates can’t stop talking about insulin. ...

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FDA accepts for priority review Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis

28 January 2020 - If approved, Dupixent would be the first biologic medicine available in the U.S. for these children. ...

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Big drug purchasers predict price hikes driven by expensive new therapies

27 January 2020 - More than two dozen big buyers of prescription medicines expect that prices will rise by an ...

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Jubilant Radiopharma Receives Approval from Health Canada for Drax Exametazime

27 January 2020 - Jubilant Radiopharma announced today that the company received approval from Health Canada for Drax Exametazine (Kit ...

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Liquidia submits new drug application for LIQ861 (treprostinil) inhalation powder to U.S. FDA for the treatment of pulmonary arterial hypertension

27 January 2020 - Liquidia Technologies today announced the submission of its New Drug Application (NDA) to the U.S. FDA ...

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Expanded access to cutting edge CAR T-cell therapy

28 January 2020 - The Australian Government is expanding access to a cutting edge and potentially curative cancer therapy for patients ...

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CMS expands coverage of next generation sequencing as a diagnostic tool for patients with breast and ovarian cancer

27 January 2020 - Final decision provides new access to Next Generation Sequencing tests for certain Medicare patients with cancer ...

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US FDA approves only triple-combination tablet with Jardiance for adults with type 2 diabetes

27 January 2020 - Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) is a once-daily therapy combining three well-established treatments in one ...

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Health Canada approves new indication for Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis

27 January 2020 -  In the Phase 3 pivotal trial, nearly 44% of patients receiving Stelara subcutaneous injections every 8 ...

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Genentech submits supplemental biologics license application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer

26 January 2020 - Application is being reviewed under FDA's Real-Time Oncology Review pilot program. ...

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EMA celebrates 25 years advancing public and animal health

27 January 2020 - This week marks EMA’s 25th anniversary.  ...

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'Cutting edge' $500,000 treatment for aggressive blood cancers

28 January 2020 - Australians battling highly aggressive blood cancers could start a groundbreaking treatment within weeks, after the federal ...

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