Questions about liver toxicity have dogged Genzyme/Isis’ Kynamro (mipomersen), despite robust LDL-lowering. An FDA panel review in October will tell whether seemingly reassuring safety data from a long-term extension study will do the trick for U.S. approval.
Ionis Pharmaceuticals Inc. will soon find out whether a long-term extension study of its cholesterol drug Kynamro (mipomersen) really puts concerns about liver safety to rest.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review the application of Kynamro for homozygous familial hypercholesterolemia on Oct. 18. The session follows the committee’s Oct. 17 review of Aegerion Pharmaceuticals Inc
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
HHS released the parameters for the MFN policy, which would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
