biological products Press Release

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Thu, 07/10/2025 - 12:24 FDA Embraces Radical Transparency by Publishing Complete Response Letters
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FDA
Fri, 09/17/2021 - 15:25 FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
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FDA
Wed, 07/28/2021 - 13:54 FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
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FDA
Sun, 05/10/2020 - 23:21 Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19
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FDA
Mon, 02/03/2020 - 15:28 FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans
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FDA
Wed, 12/18/2019 - 04:32 Trump Administration Takes Historic Steps to Lower U.S. Prescription Drug Prices
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HHS
Fri, 12/21/2018 - 18:00 FDA approves first treatment for rare blood disease
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FDA
Fri, 12/21/2018 - 17:09 FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk
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FDA
Fri, 12/21/2018 - 15:24 FDA approves new treatment for adult patients with rare, life-threatening blood disease
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FDA
Thu, 12/20/2018 - 04:03 FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
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FDA
Thu, 12/20/2018 - 02:43 FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
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FDA
Mon, 12/17/2018 - 01:25 Michigan-based food manufacturer agrees to stop operations after repeated food safety violations
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FDA
Tue, 12/11/2018 - 10:24 FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
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FDA
Mon, 12/10/2018 - 10:55 Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data
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FDA
Mon, 12/10/2018 - 09:34 FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
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FDA
Wed, 12/05/2018 - 23:59 Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDAs new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
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FDA
Fri, 11/30/2018 - 13:27 FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
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FDA
Thu, 11/29/2018 - 15:51 FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agencys ongoing Youth Tobacco Prevention Plan
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FDA
Wed, 11/28/2018 - 16:18 FDA approves first biosimilar for treatment of adult patients with non-Hodgkins lymphoma
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FDA
Wed, 11/28/2018 - 15:22 FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
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FDA
Wed, 11/28/2018 - 15:00 FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation
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FDA
Tue, 11/27/2018 - 12:57 FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients
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FDA
Sun, 11/25/2018 - 21:43 FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
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FDA
Sun, 11/25/2018 - 20:00 Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation
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FDA
Tue, 11/20/2018 - 23:00 FDA approves new treatment for patients with acute myeloid leukemia
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FDA