By: Tatiana Prowell, M.D. and Richard Pazdur, M.D. Last month, researchers at an international oncology conference in Spain reported that pertuzumab, which was FDA-approved for treatment of HER2+ metastatic breast cancer in June 2012, improved survival by an average of … Continue reading →
By: Michael R. Taylor The success or failure of our efforts to keep foods safe all over the world rests on the strength of our global partnerships and the work we can do together to verify that food safety standards … Continue reading →
David Martin, M.D., M.P.H. Cars driving on the left side of the road and exhortations to “mind the gap” when exiting the underground became a part of my daily routine when I joined the FDA Office of International Programs as … Continue reading →
聯合新聞網 張念原說,藥明康德生產的TMB-355產品,不僅獲得 FDA認證 ,其價格也較有競爭力,未來也可加速TMB-355在大陸的臨床審查、藥證申請,可謂一舉數得。 TMB-355目前已經完成美國和台灣的靜脈注射臨床二期b階段,獲得孤兒藥資格後,將和美國FDA完成協商後,可 ... and more »