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FDA

• ASH and FDA Convene Workshops on Minimal Residual Disease in CLL and AML
• February 14, 2013
• ASH and the Food and Drug Administration are cosponsoring two public workshops that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).

• FDA grants accelerated approval to pomalidomide for patients previously treated for multiple myeloma
• February 8, 2013

• On February 8, 2013, the U. S. Food and Drug Administration granted accelerated approval to pomalidomide (POMALYST^® capsules, Celgene Corporation) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

• FDA Approves Generic Version of Doxil; Approval is Expected to Help Resolve Ongoing Shortage
• February 5, 2013
• The U.S. Food and Drug Administration (FDA) approved the first generic version Doxil (doxorubicin hydrochloride liposome injection).

• FDA Grants Accelerated Approval to Ponatinib to Treat Adult Patients with Chronic Phase, Accelerated Phase, or Blast Phase CML or Ph+ALL
• December 14, 2012
• On December 14, 2012, the U. S. Food and Drug Administration granted accelerated approval to ponatinib (Iclusig™ tablets, ARIAD Pharmaceuticals, Inc.) for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.

• FDA Approves New Dosing and Administration Information for Rituximab
• October 19, 2012

• On October 19, 2012, the U. S. Food and Drug Administration approved a 90-minute infusion for rituximab (Rituxan^® Injection, Genentech, Inc.) starting at Cycle 2 for patients with non-Hodgkin’s lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during Cycle 1. Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (>5000/mcL) are not recommended to receive the faster infusion.

• FDA Approves Bosutinib For Previously Treated Adult Patients With Ph+ CML
• September 5, 2012
• On September 4, 2012, the U. S. Food and Drug Administration approved bosutinib tablets (Bosulif^®, Pfizer, Inc.) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy.

• FDA grants accelerated approval to Marqibo® for treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)
• August 9, 2012
• On August 9, 2012, the U. S. Food and Drug Administration granted accelerated approval for vinCRIStine sulfate LIPOSOME injection (Marqibo^®, Talon Therapeutics, Inc.) for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.

• Drug Shortages Provisions in Public Law No: 112-144, FDA Safety and Innovation Act
• July 10, 2012
• On July 9, 2012 President Obama signed into law legislation reauthorizing the Food and Drug Administration's user fee programs for five years and making other changes to FDA programs and policies.

• President Obama Signs FDA Bill on User Fee Programs & Drug Shortages; ASH Advocacy Successful
• July 10, 2012
• On July 9, President Barack Obama signed The Food and Drug Administration Safety and Innovation Act into law.

• Congress Passes FDA Bill on User Fee Programs & Drug Shortages; Bill Sent to President for Signature
• June 27, 2012
• On June 26, the United State Senate passed the final Prescription Drug User Fee Act (PDUFA) legislation (The Food and Drug Administration (FDA) Safety and Innovation Act, S. 3187) including important provisions to mitigate drug shortages.

• Congress Finalizes FDA Bill on User Fee Programs & Drug Shortages
• June 20, 2012
• On June 18, the United State Senate and House of Representatives filed the final Prescription Drug User Fee Act (PDUFA) legislation (The Food and Drug Administration (FDA) Safety and Innovation Act, S. 3187) including important provisions to mitigate drug shortages.

• ASH Comments to Congressional Leadership Re: Food and Drug Safety and Innovation Act of 2012
• June 8, 2012
• The American Society of Hematology is supportive of your work to develop the Food and Drug Safety and Innocation Act of 2012 (S. 3187, H.R. 5651), particularly your efforts to begin to address the probelm of shortages of drugs and biologics and would like to offer the following recommendations as you begin the work of the conference committee.

• House and Senate Pass FDA Bills on User Fee Programs & Drug Shortages; Vote on Final Legislation Expected Near July 4
• May 31, 2012
• On June 30, the U.S. House of Representative passed H.R. 5651, its version of the Prescription Drug User Fee Act (PDUFA) legislation including important provisions to mitigate drug shortages, most notably mandating an early warning system for manufacturers.

• Senate Likely to Take Up FDA Bill on User Fee Programs & Drug Shortages May 21
• May 16, 2012

• Legislation concerning Food and Drug Administration user fee programs and drug shortages is picking up speed with the Senate planning to start consideration the week of May 21 and the House of Representatives considering its version after Memorial Day.

• ASH Committee on Government Affairs Visits Congress to Discuss Research Funding and Drug Shortages
• April 19, 2012
• Following its March 21 meeting in Washington, DC, the ASH Committee on Government Affairs visited more than 40 congressional offices to explain to Members of Congress and their staff the impact of potential cuts in funding to the National Institutes of Health (NIH) on research to find cures and treatments for patients with serious hematologic diseases.

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