Latest Nephrology news and features
Latest Urology news and features
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Upsher Smith announced the completion of its Phase 3 PREVAIL study for USL255 (extended-release topiramate) as an adjunctive treatment for epilepsy in patients with refractory partial-onset seizures.
Salix announced the outcome and completion of two Phase 3 studies which evaluated the efficacy and safety of budesonide foam in the treatment of active mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis.
Jannsen R&D Ireland announced results from its Phase 3 study, PROMISE for the use of investigational protease inhibitor simeprevir in treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease.
AcelRx Pharmaceuticals' Phase 3 study with investigational sublingual sufentanil NanoTab PCA System achieved its primary efficacy endpoint.
Biogen Idec has submitted a BLA for Plegridy, a pegylated subcutaneous injectable molecular entity for relapsing forms of multiple sclerosis.
The FDA has granted sebelipase alfa Breakthrough Therapy designation for the treatment of early onset lysosomal acid lipase deficiency.
Genetech announced results from CLL11, a Phase 3 study of obinutuzumab (GA101), comparing the combination of either obinutuzumab or Rituxan and chlorambucil to chlorambucil alone in chronic lymphocytic leukemia (CLL).
The FDA has accepted Seattle Genetics' sBLA for filing of Adcetris for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
The FDA has accepted the Biologics License Application for Eloctate, a first in class recombinant factor VIII Fc fusion protein for hemophilia A treatment.
The FDA has granted Janssen R&D's NDA priority review for simeprevir in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults.
The FDA has accepted for filing Actavis' NDA for a once-weekly progestin-only transdermal contraceptive patch to prevent pregnancy in women.
The FDA has accepted for review the Biologics License Application for ragweed pollen sublingual allergy immunotherapy tablet.
Phase 3 trial evaluating Vectibix vs. Erbitux for the treatment of chemo-refractory metastatic colorectal cancer meets its primary endpoint for overall survival.
Baxter's immunoglobulin study for the treatment of Alzheimer's has been discontinued after a Phase 3 study failed to meet co-primary endpoints.
Antibiotic candidate, ceftolozane/tazobactam, has been granted Fast Track Status for the treatment of hospital-acquired bacterial pneumonia/ acquired bacterial pneumonia and complicated urinary tract infections.
