Drugs

Octapharma’s Fibryga OK’s for Expanded Use

FDA has approved an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). The company says AFD often results from severe bleeding and can weaken blood clot formation, increasing hemorrhage risk in patients.

The expanded approval was based on the FIBRES (FIBrinogen REplenishment in Surgery) study that demonstrated that fibrinogen concentrate was non-inferior to cryoprecipitate (standard of care) and may be used instead of cryoprecipitate for treating bleeding related to AFD, Octapharma says.

Finryga was originally approved in 2017 for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome