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117 articles found
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FDA Takes Additional Steps to Advance Decentralized Clinical TrialsToday, the U.S. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related... -
FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of MakenaToday, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to...
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FDA Approves First Over-the-Counter Naloxone Nasal SprayToday, 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...
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FDA Grants Accelerated Approval for Alzheimer’s Disease TreatmentToday, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of...
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FDA Approves New HIV Drug for Adults with Limited Treatment OptionsToday, the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose...
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FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter UseAgency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Ce...
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FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative DiseasesToday, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partn...
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FDA Approves First Targeted Therapy for HER2-Low Breast CancerToday, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (sp...
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FDA Provides Update on Agency Response to Monkeypox OutbreakToday, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and ther...
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FDA Roundup: July 22, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the guidance for industry entitled “Failure to Respond to an...