FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants
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Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today's actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc.
FDA approves first oral treatment for postpartum depression
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The U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.
FDA approves first nonprescription daily oral contraceptive
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Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy - the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
FDA approves first gene therapy for treatment of certain patients with Duchenne muscular dystrophy
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Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy.
FDA announces additional steps to modernize clinical trials
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Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products.
FDA approves first drug to treat agitation symptoms associated with dementia due to Alzheimer's disease
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Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.
FDA approves first respiratory syncytial virus (RSV) vaccine
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The U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
More Pharma News ...
- FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation
- FDA approves first over-the-counter naloxone nasal spray
- FDA grants Accelerated Approval for Alzheimer's disease treatment
- FDA approves new HIV drug for adults with limited treatment options
- FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer
- FDA approves first gene therapy to treat adults with Hemophilia B
- FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease