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FDA advisory committee expresses support for three therapies

FDA advisory committee expresses support for three therapies
HemOnc Today, June 25, 2017

An FDA advisory panel expressed support for three oncology and hematology drug products during a May 24-25 session.

The Oncologic Drugs Advisory Committee (ODAC) reviewed and voted in favor of approval for neratinib (Nerlynx, Puma Biotechnology) for the treatment of early-stage, HER-2–positive breast cancer, L-glutamine powder (Emmaus Medical) for the treatment of sickle cell disease, and a biosimilar version of Amgen’s epoetin alfa for the treatment of anemia from various causes.

FDA News

FDA accepts new drug application for Tavalisse to treat immune thrombocytopenia

June 20, 2017
The FDA accepted the new drug application for fostamatinib disodium, an oral investigational drug candidate in development to treat patients with chronic or persistent…

Five updates for World Sickle Cell Day

June 19, 2017
In recognition of World Sickle Cell Day, the American Society of Hematology launched an effort to develop clinical practice guidelines on the management of sickle cell…
In the Journals Plus

Ferrous sulfate effective for pediatric iron-deficiency anemia

June 13, 2017
Infants and children aged 9 months to 4 years with nutritional iron-deficiency anemia had a greater increase in hemoglobin concentration at 12 weeks with ferrous sulfate…
CME CNE CPE

Individualized Prophylaxis in Hemophilia

Support for this activity has been made possible through an educational grant from Bayer HealthCare Pharmaceuticals

This program will provide education for hematologists, nurses, pharmacists, and other healthcare providers involved in…
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Video
Meeting News Coverage

VIDEO: Direct oral anticoagulants show promise for reducing stroke, bleeding risk in patients with cancer

January 6, 2017
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ASCO Annual Meeting

ASCO Annual Meeting

CME

Bridging the Gap from Knowledge to Practice in CRPC

This activity is supported by educational funding provided by AbbVie Inc.; Astellas Scientific and Medical Affairs, Inc. and Medivation; and Sanofi US.

The selection of therapy for patients with castration-resistant prostate cancer (CRPC) remains challenging. Review…
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FDA News

FDA advisory committee expresses support for three therapies

HemOnc Today, June 25, 2017
An FDA advisory panel expressed support for three oncology and hematology drug products during a May 24-25 session. The Oncologic Drugs Advisory…

FDA News

FDA accepts new drug application for Tavalisse to treat immune thrombocytopenia

June 20, 2017
The FDA accepted the new drug application for fostamatinib disodium, an oral investigational drug candidate in development to treat patients with…

Five updates for World Sickle Cell Day

June 19, 2017
In recognition of World Sickle Cell Day, the American Society of Hematology launched an effort to develop clinical practice guidelines on the…

In the Journals Plus

Ferrous sulfate effective for pediatric iron-deficiency anemia

June 13, 2017
Infants and children aged 9 months to 4 years with nutritional iron-deficiency anemia had a greater increase in hemoglobin concentration at 12 weeks…

FDA News

FDA accepts Bioverativ’s investigational new drug application for BIVV001

June 12, 2017
The FDA accepted the investigational new drug application for BIVV001, according to the agent’s manufacturer. BIVV001 (Bioverativ) is a novel…

FDA News

FDA approves Rebinyn for hemophilia B

June 1, 2017
The FDA approved the biologics license application for coagulation Factor IX (recombinant), glycoPEGylated for the treatment of adults and children…

In the Journals Plus

Second-line therapies do not improve OS in non-deleted 5q lower-risk myelodysplastic syndromes

June 1, 2017
No commonly used second-line treatments for patients with non-deleted 5q lower-risk myelodysplastic syndromes improved patients’ survival, a

FDA News

Eight FDA updates

May 26, 2017
The FDA has announced several decisions and opinions related to hematology and oncology in the past month. HemOnc Today summarizes eight FDA…

FDA News

FDA advisory committee supports biosimilar for anemia

May 25, 2017
An FDA advisory panel today supported approval of a biosimilar version of Amgen’s epoetin alfa for the treatment of anemia from various causes…

FDA News

FDA advisory committee expresses support for L-glutamine for sickle cell disease

May 24, 2017
An FDA panel today expressed its support for the approval of L-glutamine powder in the treatment of sickle cell disease. The Oncologic Drugs Advisory…

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