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Specialty Pharma Journal Specialty, Precision & Technology

Breaking News

FDA Approves Gavreto for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM
Natera Announces SMART Study Data for Aneuploidy and 22q Unblinded
Aimmune Agrees to be Acquired by Nestlé Health Science for $2 Billion
Twist Bioscience Announces Potent SARS-CoV-2 Neutralizing Data from COVID-19 Therapeutic Antibody Program
Final Analysis of the Observational GioTag Study: Sequential Afatinib and Osimertinib in Patients with EGFR Mutation-Positive NSCLC
Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne Muscular Dystrophy and All Other Indications
FDA Approves Onureg, a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
FDA Accepts Vertex’s sNDA for Trikafta, Symdeko and Kalydeco for Additional CFTR Mutations
Gilead Sciences and Jounce Therapeutics Announce Exclusive License Agreement for Novel Immunotherapy Program

Tag Archives: Onglyza

April, 2015

14 April
FDA Panel Recommends Adding Heart Failure Risk on Onglyza Label

An advisory panel to US health regulators voted that AstraZeneca’s diabetes drug Onglyza should include new safety information about the risk of heart failure. An advisory panel to the US Food and Drug Administration (FDA) met Tuesday to review data from a large scale cardiovascular (CV) outcomes trial that assessed …
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10 April
FDA Says AstraZeneca’s Onglyza May Increase Death Risk

The US Food and Drug Administration (FDA) staff reviewers have raised serious concerns of safety issues associated with AstraZeneca’s diabetes drug Onglyza. The agency’s concerns come a few days ahead of a committee meeting to discuss the safety of DPP-4 inhibitors. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is …
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