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News
Abortion Drug Law in Louisiana Heightens Hemorrhage Risk for Pregnant Patients
1+ mon, 1+ week ago (1077+ words) “Those medications have helped save thousands of lives, and we just need to get to a safe space where prescribers and patients don't have any worries." Over the past decade, Louisiana hospitals began stocking specialized carts designed to treat hemorrhages,…...
FDA Monthly Preview: Key August Decisions to Watch
1+ mon, 1+ week ago (276+ words) Several FDA decisions across multiple specialties are expected this month. Source: Bristol Myers Squibb Savara announced that the FDA continues to review its biologics license application for MOLBREEVI (molgramostim inhalation solution) for autoimmune pulmonary alveolar proteinosis, with an August 22, 2026, PDUFA…...
FDA Licenses First Freeze-Dried Plasma
1+ mon, 2+ week ago (171+ words) The room-temperature product is indicated for adult patients when other plasma products are unavailable. The US Food and Drug Administration has licensed Ezplaz Freeze Dried Plasma. The lyophilized plasma product can be stored at room temperature and rapidly reconstituted for…...
FDA Approves Centanafadine for ADHD
1+ mon, 2+ week ago (195+ words) The first approved norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD demonstrated symptom improvements as early as week 1 in phase 3 trials. Across the phase 3 clinical program, centanafadine was generally well tolerated, according to the company. The most common adverse reactions…...
FDA Approves Ophthalmic Bevacizumab
1+ mon, 2+ week ago (286+ words) Conexiant The US Food and Drug Administration has approved bevacizumab-vikg (LYTENAVA) for the treatment of neovascular age-related macular degeneration, also known as wet age-related macular degeneration, according to a press release from Outlook Therapeutics Bob Jahr, chief executive officer of…...
FDA Approves Furoscix ReadyFlow
1+ mon, 2+ week ago (263+ words) Conexiant Furoscix ReadyFlow (furosemide injection) received US Food and Drug Administration approval for the treatment of edema in adults with heart failure or chronic kidney disease, according to a press release from MannKind Corporation The product delivers furosemide by a…...
FDA Approves Zidesamtinib for ROS1 Lung Cancer
1+ mon, 2+ week ago (214+ words) Conexiant The US Food and Drug Administration has approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer following prior treatment with a ROS1 kinase inhibitor, according to a press release from GSK The approval follows…...
Ixekizumab May Improve Early Response After Secukinumab Failure
1+ mon, 3+ week ago (257+ words) A real-world cohort found faster early skin responses with ixekizumab than with guselkumab or ustekinumab following secukinumab treatment failure, while all three biologics demonstrated favorable safety. Patients with moderate-to-severe plaque psoriasis who switched to ixekizumab following secukinumab treatment failure achieved…...
Can Patients Switch to Biosimilar Aflibercept?
1+ mon, 3+ week ago (194+ words) A 20-week INSIGHT extension suggests that switching from reference aflibercept to MYL-1701P maintained comparable safety, visual, and anatomic outcomes in patients with diabetic macular edema. Patients with diabetic macular edema who switched from reference aflibercept to the biosimilar aflibercept MYL…...
FDA Grants Traditional Approval to Iptacopan in Primary IgAN
1+ mon, 3+ week ago (230+ words) Conexiant The US Food and Drug Administration granted traditional approval to iptacopan (Fabhalta) to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk of disease progression, according to a press release from Novartis Novartis said iptacopan…...