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Takeda Pharmaceutical and BioNumerik Pharmaceuticals have announced the results of two Phase III trials of Tavocept, an investigational drug with potential for oncology and non-oncology indications developed by BioNumerik.
Takeda Pharmaceuticals announced the FDA has approved its new drug application for duetact (pioglitazone HCl and glimepiride) for the treatment of Type 2 diabetes.
Abbott announced that the FDA has approved Humira (adalimumab) for reducing signs and symptoms in patients with active ankylosing spondylitis, an autoimmune disease that affects the spine and large peripheral joints and causes inflammatory back pain and stiffness.
MedImmune announced it has submitted to the FDA a supplemental biologics license application (sBLA) for use of CAIV-T (cold adapted influenza vaccine, trivalent) in children 12 months to 5 years of age who do not have a history of wheezing or asthma.
Critical Therapeutics announced that it has submitted a new drug application (NDA) to the FDA for the twice-daily, controlled-release formulation of zileuton (zileuton CR).
Merck announced that its new drug application for MK-0431A, the company's investigational oral medicine combining Januvia (sitagliptin phosphate) and metformin for Type 2 diabetes, has been accepted for review by the FDA.