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Latest News

FDA Releases Biosimilars Action Plan

FDA released the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars.   The BAP is focused on four key areas: improving the efficiency of the biosimilar and interchangeable product development and approval process; maximizing scientific and...

agios pharma

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific...

Cancer Groups Object to Medicare Proposals to Cut Part B

Cancer Groups Object to Medicare Proposals to Cut Part B Source: Medscape – Kerry Dooley Young – July 19, 2018 Oncology groups are opposed to some of the proposals currently under consideration in the United States that are aimed at reducing the high cost of drugs. In recent years, a flood of new cancer drugs has...

XTANDI Significantly Extended Metastasis-Free Survival in Patients with Nonmetastatic CRPC

Astellas Pharma US, Inc. and Pfizer Inc. are pleased to announce that XTANDI is now indicated for the treatment of patients with CRPC.1 PROSPER was a multinational, randomized, double-blind, placebo-controlled phase 3 study of XTANDI + LHRH therapy† in patients with nonmetastatic CRPC who had progressed on LHRH therapy.†1,2 In PROSPER, 1401 patients with nonmetastatic...

FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer

On July 18, 2018, the Food and Drug Administration expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. FDA also approved ribociclib in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or...

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