Hemophilia Federation of America is a national nonprofit organization that assists, educates, and advocates for the bleeding disorders community.
Note: The following is a summary of a letter dated Feb. 27, 2018, from the US Food and Drug Administration (FDA) to CSL Behring. You can read the original letter here. The FDA has advised CSL Behring that the company’s promotional materials make misleading claims about the effectiveness of its Idelvion (Factor IX) product. “Such […]
Note: The following is edited from a press release from Alnylam Pharmaceuticals. Read the full press release in its entirety here. Alnylam Pharmaceuticals Inc., a RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced Dec. 15, 2017, the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including […]
Note: The following is the full text of an email communication received by HFA from Bayer HealthCare Pharmaceuticals: Bayer in consultation with the FDA has voluntarily recalled approximately 300 vials (part of one lot) of Kogenate® FS, Antihemophilic Factor (Recombinant) in the U.S. as an excipient, used to stabilize the product during manufacturing, may not conform […]
Note: The following is edited from a press release from Shire. Read the full press release in it’s entirety here. Shire plc recently announced that the U.S. Food and Drug Administration (FDA) has approved Adynovate, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA […]
The following is excerpted from an FDA news release. To read the release in its entirety, click here. The U.S. Food and Drug Administration is warning about the risk that some of the new direct-acting antiviral medicines for hepatitis C (HCV) can reactivate the hepatitis B virus (HBV) among patients who have had HBV. “In a […]
For the past few months, HFA has been monitoring the progression of the Zika virus in the United States. Since the first reported cases of Zika virus reaching the United States in January, there have been thousands of additional cases. According to the Centers for Disease Control (CDC), the follow cases and causes of transmission […]
In January of this year, the Food and Drug Administration (FDA) revised its donor deferral policy surrounding men who have sex with men (MSM). On July 26, 2016, the FDA issued another request for comments regarding the MSM donor deferral policy. Current policy permits blood donations by MSM provided that the donor has not had […]
Note: The below is an edited version of a press release by Spark Therapeutics. The original release can be read in it’s entirety here. Spark Therapeutics and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies’ SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a […]
In September 2014, the U.S. Food and Drug Administration hosted a public meeting as part of it’s Patient-Focused Drug Development initiative, a 5 year initiative to learn more from patients across a variety of disease and disorders. We were proud to be a part of this meeting and provided support to several of the patient […]
Note: The below is an edited version of a press release by CSL Behring. The original release can be read in it’s entirety here. KING OF PRUSSIA, Pa., May 26, 2016 — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor […]
Sign up for E-mails, Dateline Newsletter, and other ways to stay connected.