FDA approves first nonprescription daily oral contraceptive
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- Category: FDA
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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- Category: FDA
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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- Category: FDA
Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without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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- Category: FDA
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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- Category: FDA
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.
FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation
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- Category: FDA
Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen (treatment such as radiation or chemotherapy).
FDA approves first over-the-counter naloxone nasal spray
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- Category: FDA
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use - the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.
More Pharma News ...
- 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
- FDA approves first systemic treatment for alopecia areata
- FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain