lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

22 Febbraio 2019

FDA Grants Entrectinib Priority Review for NTRK+ Tumors and ROS1+ NSCLC

February 19, 2019 - The FDA has granted a priority review designation to a new drug application (NDA) for entrectinib as a treatment for select adult and pediatric patients with NTRK fusion–positive locally advanced or metastatic solid tumors, as well as patients with ...
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22 Febbraio 2019

FDA Grants Ivosidenib Priority Review for Frontline IDH1+ AML

February 20, 2019 - The FDA has granted a priority review to a supplemental new drug application (sNDA) for ivosidenib for the frontline treatment of patients IDH1-mutant acute myeloid leukemia (AML) who are ineligible for standard chemotherapy. The sNDA is based on data ...
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22 Febbraio 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes

February 21, 2019 - More than 54 years after the landmark Surgeon General’s report on smoking and health, tobacco use - primarily cigarette smoking - remains the leading cause of preventable disease and death in the U.S., responsible for 480,000 premature deaths each ...
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22 Febbraio 2019

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

February 21, 2019 - The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens ...
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22 Febbraio 2019

Bevacizumab Biosimilar Approved in Europe

February 19, 2019 - The European Commission has approved PF-06439535, a bevacizumab biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic, or recurrent non–small cell lung ...
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22 Febbraio 2019

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

February 21, 2019 - The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP ...
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19 Febbraio 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

February 15, 2019 - In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may ...
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19 Febbraio 2019

15 febbraio 2019 – Comunicazione EMA su medicinali a base di fenspiride

19 Febbraio 2019

FDA Grants Pembrolizumab/Axitinib Combo Priority Review for Frontline RCC

February 15, 2019 - The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the combination of pembrolizumab and axitinib as a frontline treatment for patients with advanced renal cell carcinoma (RCC). The application ...
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19 Febbraio 2019

Role of big data for evaluation and supervision of medicines in the EU

February 15, 2019 - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support of the evaluation and supervision of medicines by regulators were published today as part of a PDF iconsummary report of the ...
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