FDA approves nasal spray influenza vaccine for self- or caregiver-administration
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- Category: FDA
Today, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age.
FDA approves first nasal spray for treatment of anaphylaxis
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- Category: FDA
The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).
"Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections," said Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research.
FDA approves nonsteroidal treatment for Duchenne muscular dystrophy
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- Category: FDA
The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
FDA approves first gene therapies to treat patients with sickle cell disease
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- Category: FDA
Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.
FDA approves first therapy for rare type of non-cancerous tumors
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The U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
First electronic product information (ePI) published for selected human medicines
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- Category: EMA
The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU).
The product information of a medicine includes its summary of product characteristics, labelling and package leaflet.
FDA approves first treatment for patients with rare inherited blood clotting disorder
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- Category: FDA
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.
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- FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants
- FDA approves first oral treatment for postpartum depression
- FDA approves first nonprescription daily oral contraceptive
- FDA approves first gene therapy for treatment of certain patients with Duchenne muscular dystrophy
- FDA announces additional steps to modernize clinical trials
- FDA approves first drug to treat agitation symptoms associated with dementia due to Alzheimer's disease
- FDA approves first respiratory syncytial virus (RSV) vaccine