Combination Drug for Adults with T2D is Granted FDA Approval
May 6th 2019Dapagliflozin is a selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor that is combined with a dipeptidyl peptidase‑4 (DPP‑4) inhibitor, saxagliptin; and metformin hydrochloride extended release.
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Trellegy Ellipta Hits Phase 3 Asthma Marks, Eyes New Indication
May 5th 2019Pivotal phase 3 trial results show benefits for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy Ellipta) in patients with uncontrolled asthma compared with standard FF/VI (Breo Ellipta) therapy.
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Beta Interferon Treatment Shown to Improve Long-Term Survival in Patients with MS
May 4th 2019In the first and largest study of its kind, researchers from the University of British Columbia (UBC) and Vancouver Coastal Health Research Institute aimed to assess mortality associated with beta interferons for the treatment of MS.
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Adjuvant Treatment for HER2+ Early Breast Cancer Receives FDA Approval
May 4th 2019The FDA rapidly reviewed and approved Genentech’s application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, leading to an approval 12 weeks after completing the submission.
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New Data Support Viral Suppression as Key to Preventing HIV Transmission
May 3rd 2019Results of the recent study, published in The Lancet, support the benefits of early testing and treatment for HIV, as well as the message of Prevention Access Campaign’s U=U (undetectable equals untransmittable) initiative.
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Ivosidenib as Monotherapy Granted FDA Approval for Certain Patients with IDH1 Mutant AML
May 3rd 2019The sNDA was granted Priority Review and accepted under the agency's Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency.
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Ivosidenib as Monotherapy Granted FDA Approval for Certain Patients with IDH1 Mutant AML
May 3rd 2019The sNDA was granted Priority Review and accepted under the agency's Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency.
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