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Citing significant price increases for certain generic drugs, House Republicans have sent a letter to Acting FDA Commissioner Stephen Ostroff with concerns about the agency’s process for approving ANDAs. Read More
The FDA has given its blessing to Wellstat Therapeutics’ Vistogard for the emergency treatment of adults and children who receive an overdose of chemotherapy treatment fluorouracil or capecitabine. Read More
The FDA has granted approval to Genentech’s Alecensa for metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer in patients whose disease has worsened after taking Pfizer’s Xalkori, or who could not tolerate the treatment. Read More
The treatment is for patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma and transformed follicular lymphoma. Read More