Drugs

FDA OKs Expanded Tibsovo Indication Plus Diagnostic Test

FDA has approved a Servier Pharmaceuticals sNDA expanding the indication of Tibsovo (ivosidenib tablets) to treat adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-approved test. At the same time, the agency gave premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to identify patients with IDH1 mutated cholangiocarcinoma who may be candidates for Tibsovo.

Servier says the sNDA received priority review and was based on data from the ClarIDHy study, the only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.

Tibsovo also is approved in the U.S. as monotherapy for treating adults with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutated AML who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

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