Best Read Articles on FDA Approvals in 2021
The approval of the generic version of smoking-cessation drug Chantix (varenicline) garnered a lot of attention as did the OKs of Besremi (ropeginterferon alfa-2b-njft), a treatment for polycythemia vera, and Trudhesa (dihydroergotamine mesylate), a nasal spray for acute treatment of migraines.
FDA Approves Generic of Chantix, Pfizer's Smoking Cessation Drug
This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.
FDA Approves Treatment for Rare Blood Disease
Besremi is the first interferon approved to treat a disease that causes the overproduction of red blood cells.
FDA Approves Therapy for Age-Related Blurry Vision
Vuity, developed by Allergan, is a once-daily eye drop to treat presbyopia.
FDA Clears Novel Nasal Spray for Migraine
The therapy, to be launched in October, is delivered quickly to the bloodstream by targeting the upper nasal space.
FDA Approves Novel Therapy for Macular Degeneration
Genentech’s Susvimo is a refillable implant that delivers medication continuously for up to six months.
Capricor Completes BLA for Deramiocel for Duchenne Cardiomyopathy
January 3rd 2025Deramiocel is a cell therapy that has healing effects in muscle cells. If approved, deramiocel would be a once-quarterly therapy and the first specifically approved for cardiomyopathy in patients with Duchenne muscular dystrophy.
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