FDA Advisory Committee Recommends Against Approving Abuse-Deterrent Pain Med
June 28th 2018The FDA voted against recommendign oxycodone extended-release capsules (REMOXY ER, Pain Therapeutics) for approval for the management of pain severe enough to require long-term, around-the-clock opioid treatment, during a joint meeting of the agency’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), and the Drug Safety and Risk Management Advisory Committee (DSARM).
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Combo Treatment for Advanced BRAF-Mutant Melanoma Receives FDA Approval
June 27th 2018The FDA has granted approval to Array BioPharma’s encorafenib (Braftovi) capsules in combination with binimetinib (Mektovi) tablets for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E or BRAFV600K mutation.
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Repatha Significantly Improved Cholesterol Levels in High-Risk Patients with Type 2 Diabetes
June 26th 2018New data demonstrate that evolocumab (Repatha) significantly reduced low-density lipoprotein cholesterol and non-high density lipoprotein cholesterol in patients with type 2 diabetes plus hypercholesterolemia or mixed dyslipidemia.
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Relapsed/Refractory Multiple Myeloma Treatment Improves Progression-Free Survival in Study
June 26th 2018Elotuzumab with pomalidomide and low-dose dexamethasone met its primary endpoint in showing a statistically significant, clinically meaningful improvement in progression-free survival in patients with relapsed/refractory multiple myeloma.
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FDA Approves Plazomicin for Treatment of Complicated Urinary Tract Infection
June 26th 2018Officials with the FDA have approved plazomicin (Zemdri, Achaogen) for the treatment of adults with complicated urinary tract infections (cUTIs), caused by certain Enterobacteriaceae, in patients with limited or no alternative treatment.
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FDA Approves Groundbreaking Drug for Treating Rare, Severe Forms of Epilepsy
June 25th 2018Officials with the FDA have approved cannabidiol oral solution (Epidiolex) for the treatment of seizures associated with 2 rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients aged 2 years and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana, and is the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
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New Data Show Oral Semaglutide Significantly Reduced A1C in Adults with Type 2 Diabetes
June 25th 2018Newly published findings from the PIONEER 1 phase 3a trial show that once-daily once-daily oral semaglutide was associated with significant reductions in blood sugar in adults with type 2 diabetes.
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