martedì, 5 maggio 2026

Notizie Newsletter

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

June 20, 2019 - Addressing the crisis of opioid addiction is an issue of great concern for our nation and remains a top public health priority for the FDA. The agency continues to take new steps to confront this crisis, while also paying careful attention to the needs of ...
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FDA Issues Complete Response Letter for Quizartinib in AML

June 21, 2019 - The FDA has issued a complete response letter to Daiichi Sankyo informing the company that its new drug application (NDA) would not be approved for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid ...
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U.S. Cancer Survivors Numbered Nearly 17 Million at the Start of 2019

June 17, 2019 - There were more than 16.9 million Americans with a history of cancer on January 1, 2019, and that number is projected to reach more than 22.1 million by 2030 based on the growth and aging of the population alone, according to estimates from Cancer Treatment ...
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Olaparib Approved in Japan for Frontline Maintenance in Ovarian Cancer

June 19, 2019 - Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved olaparib as a maintenance treatment for patients with BRCA-mutant ovarian cancer after undergoing first-line chemotherapy. The approval was based on findings from the randomized, double-blinded, ...
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Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

June 18, 2019 - The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. ...
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Highlights of Management Board meeting: June 2019

June 17, 2019 - At its 12-13 June meeting, the Board heard an update on EMA’s first three months in its temporary building in Amsterdam Sloterdijk and the preparations for the Agency’s move to its final premises in the Zuidas area of Amsterdam. Construction of ...
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18 giugno 2019 – Inserimento web based nuove AIC – Registro Olaparib (AstraZeneca)

18 giugno 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Sonidegib (Novartis)

18 giugno 2019 – Modifica scheda di monitoraggio Registro Vismodegib (Roche)

19 giugno 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Cabozantinib (Ipsen)