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Niraparib almost quadrupled progression-free survival in certain ovarian cancer patients compared to placebo, according to results from a Phase III trial. Read More
Sun Pharmaceuticals has initiated a recall of more than 30,000 bottles of bupropion hydrochloride extended-release tablets for the treatment of major depressive disorder and seasonal affective disorder. Read More
The UK’s price watchdog is not recommending Janssen’s Imbruvica for the treatment of Waldenstrom's macroglobulinemia, a rare type of non-Hodgkin's lymphoma. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
Sen. Charles Grassley (R-Iowa) wants the Department of Justice to provide details on a settlement Mylan reached to resolve claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program. Read More
The FDA has determined that the results of the Xarelto clinical trial were not affected by a faulty monitoring device used in the trial, and that the drug’s approval will stand. Read More
Accessing a company’s policy on expanded access might be easier said than done, as most companies fail to post this information on their websites, a recent analysis found. Read More