The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its refusal of marketing authorization for Syfovre. Medscape Medical News
Tag: News Alert
New Drugs Turned Down by EU Safety Assessor
Drugs for ALS, age-related macular degeneration, and Duchenne muscular dystrophy did not get the green light due to lack of evidence. Medscape Medical News
FDA OKs High Concentration of Adalimumab Biosimilar Cyltezo
Unlike the low-concentration formulation of adalimumab-adbm, launched July 1, 2023, this high-concentration version has not yet been granted an interchangeability designation. Medscape Medical News
FDA OKs High-Concentration of Adalimumab Biosimilar Cyltezo
Unlike the low-concentration formulation of adalimumab-adbm, launched July 1, 2023, this high-concentration version has not yet been granted an interchangeability designation. Medscape Medical News
CDC Investigating Reactions Linked to Counterfeit ‘Botox’
Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism. MDedge News
FDA OKs Ninth Humira Biosimilar, With Interchangeability
The drug, adalimumab-afzb (Abrilada), is the second adalimumab biosimilar approved with interchangeability status. It will be available later this month. Medscape Medical News
FDA OKs First Drug for Geographic Atrophy, a Major Cause of Adult Blindness
"The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade." FDA Approvals
FDA Approves Botox Challenger Daxxify for Frown Lines
DaxibotulinumtoxinA-lanm is the first and only peptide-formulated neuromodulator to reduce frown lines, with results lasting longer than conventional neuromodulators, according to the manufacturer. Medscape Medical News
White House Declares Monkeypox a Public Health Emergency
Intradermal injections that use one fifth of the normal dose of the Jynneos vaccine will extend the limited reach of the current supply, which is under high demand. Medscape Medical News
FDA Approves Brolucizumab for Diabetic Macular Edema
Brolucizumab wins approval for diabetic macular edema but with a warning of retinal vasculitis and retinal vascular occlusion. FDA Approvals
New Contact Lens Elutes Antihistamine for Ocular Allergy
A new contact lens that elutes antihistamine has been approved by the US Food and Drug Administration as a treatment for ocular allergies. FDA Approvals
FDA Approves Faricimab for nAMD and Diabetic Macular Edema
The US Food and Drug Administration has approved faricimab, a drug with the potential to reduce the number of injections needed to treat diabetic macular edema and neovascular age-related macular degeneration. FDA Approvals
Novel Drug, First Tx for Rare Uveal Melanoma
A novel drug, the first in its class, is also the first treatment approved for use in uveal melanoma, a rare cancer of the eye, after it was shown to improve overall survival. FDA Approvals
Novel Drug, First Tx Approved for Rare Uveal Melanoma
A novel drug, the first in its class, is also the first treatment approved for use in uveal melanoma, a rare cancer of the eye, after it was shown to improve overall survival. FDA Approvals
FDA Approves Eye Drops for Presbyopia
The first topical preparation to treat presbyopia — farsightedness caused by loss of elasticity of the lens of the eye, typically occurring in middle and old age — has won approval from the FDA. FDA Approvals
FDA Approves Drugs for Wet AMD, Macular Edema Due to Uveitis
Wet AMD gets Susvimo, an intravitreal ranibizumab injection, and macular edema gets Xipere, a triamcinolone acetonide injectable suspension. FDA Approvals
FDA Approves First Nasal Spray for Dry Eye
The FDA has approved the first-ever nasal spray to treat dry eye disease. It provides an alternative to immunomodulators. FDA Approvals
FDA Approves Ranibizumab Biosimilar
Byooviz has the potential to be less expensive than Lucentis, the reference product. FDA Approvals
2021 Match Sets Records: Who Matched and Who Didn’t?
Despite COVID upending the process, the NRMP reports record numbers, with total and first-year positions both up from 2020. Fill rates increased across the board, even as some candidates missed out. Medscape Medical News
EMA Warns of Eylea Injection Risk
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