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Recap 2023- From postpartum depression to Alzheimer’s disease, here are some crucial USFDA approvals this year
时间:2024-06-02 05:17:19 阅读(143)
Recap 2023: From postpartum depression to Alzheimer’s disease, here are some crucial USFDA approvals this year
The United States Food and Drug Administration (FDA) approves a wide range of innovative drugs and products that play a crucial role in improved patient outcomes.
Based on the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.
In 2023 to date, 55 novel drugs have been approved by the USFDA. From Alzheimer’s disease and cancer to migraines, menopausal symptoms and post-partum depression, these approved drugs cater to a wide range of medical conditions.
Here are the top 10 drugs that are going to play a crucial in patient care and treatment:ORSERDU (elacestrant): The drug was approved to manage advanced metastatic breast cancer. Orerdu (elacestrant) is a selective oestrogen receptor degrader (SERD) marketed by Stemline Therapeutics – a subsidiary of Menarini in the United States.ZURZUVAE (zuranolone): The drug was approved to treat postpartum depression. Zurzuvae (zuranolone) is a gamma-aminobutyric acid (GABA) positive allosteric modulator developed by Sage Therapeutics and Biogen.VEOZAH (fezolinetant): The drug was approved to manage menopausal hot flushes. Vezoah (fezolinetant) is a neurokinin (NK) 3 antagonist marketed by Astellas Pharma.ZAVZPRET (zavegepant): The drug approved to treat migraine. Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) antagonist nasal spray developed by Pfizer, in collaboration with Bristol Myers Squibb.VOWST (fecal microbiota spores): The drug was approved to prevent recurrent Clostridioides difficile infection. The bacteria causes diarrhoea and colitis. Vowst (fecal microbiota spores) is a microbiome modulator developed by US-based biotech company Seres Therapeutics and marketed by Nestlé.LEQEMBI (lecanemab): The drug was approved to treat Alzheimer’s disease. Leqembi (lecanemab) is an anti-beta-amyloid (Abeta) protofibrils mAb marketed by Eisai and administered via intravenous infusion.SKYCLARYS (omaveloxolone): The drug was approved to treat Friedreich’s ataxia. Skyclarys (omaveloxolone) is a nuclear factor erythroid derived 2 (Nrf2) activator developed by Reata Pharmaceuticals.ELEVIDYS (delandistrogene moxeparvovec): The drug was approved to treat Duchenne muscular dystrophy. Elevidys (delandistrogene moxeparvovec) is a micro-dystrophin gene therapy marketed by Sarepta Therapeutics.POMBILITI (cipaglucosidase alfa): The drug was approved to treat Pompe disease. Pombiliti was approved by the FDA in September and will be distributed and marketed by Amicus Therapeutics.NARCAN NASAL SPRAY (naloxone hydrochloride): The drug was approved to treat opioid overdose. The FDA previously approved NARCAN nasal spray in 2015 for prescription use. This year’s approval allows over-the-counter (OTC) use.
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