U.S. Food and Drug Administration Press Release

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Thu, 03/20/2025 - 18:09 BD Announces Milestone in Clinical Trial for Use of Bioabsorbable GalaFLEX LITE Scaffold in Breast Implant Revision Surgery
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bd
Thu, 03/20/2025 - 13:59 HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
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FDA
Mon, 03/17/2025 - 11:16 OPKO Health and Entera Bio Enter into Collaboration Agreement to Advance Oral GLP-1/Glucagon Tablet Candidate into the Clinic to Treat Obesity and Metabolic Disorders
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OPKO
Fri, 03/14/2025 - 15:09 FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year
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FDA
Thu, 02/27/2025 - 04:39 US FDA grants Priority Review to Sobis supplemental Biologics Licence Application (sBLA) for Gamifant (emapalumab-lzsg)
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Swedish Orphan ...
Fri, 02/21/2025 - 13:51 FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
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FDA
Fri, 02/14/2025 - 20:25 FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
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FDA
Wed, 02/05/2025 - 13:52 FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
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FDA
Thu, 01/30/2025 - 19:52 FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
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FDA
Thu, 01/30/2025 - 13:52 FDA Supports Swapping Single-Use Containers for Reusable, Refillable Ones
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Center for Biol...
Sat, 01/18/2025 - 07:15 FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.
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Philip Morris
Thu, 01/16/2025 - 21:06 Proposal to Lower Nicotine Levels Represents Historic Step Forward for Public Health
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Truth Initiative
Thu, 01/16/2025 - 20:55 FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review
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FDA
Wed, 01/15/2025 - 16:04 FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
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FDA
Tue, 01/14/2025 - 23:32 ACS CAN Applauds FDA Proposed Rule on Mandatory Front-of-Package Labeling Requirements
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ACS CAN
Tue, 01/14/2025 - 14:55 FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods
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FDA
Thu, 12/19/2024 - 00:39 FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
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FDA
Wed, 12/11/2024 - 22:31 Liquet Medical Inc. Receives FDA 510(k) Clearance for the Versus Catheter
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VABIO
Tue, 10/29/2024 - 02:46 Proregulations' Comprehensive Regulatory Consulting Services Help Gain a Competitive Edge in the North American Market
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proregulations
Tue, 08/27/2024 - 18:15 FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes
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FDA
Thu, 08/22/2024 - 15:53 FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
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FDA
Thu, 08/22/2024 - 07:28 Exact Sciences Announces First Patient Enrolled in its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence Study
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Exact Sciences
Wed, 08/21/2024 - 22:56 ReAlta Granted FDA Orphan Drug Designation and Fast Track Designation for RLS-0071 for the Treatment of Steroid-Refractory Acute Graft-versus-Host Disease
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VABIO
Sat, 08/17/2024 - 10:37 FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis
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FDA
Thu, 08/08/2024 - 13:29 FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
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FDA