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FDA Approvals News LIVE

Welcome to the frontline of medical breakthroughs. Our FDA approval news feed is your window into the high-stakes world of drug and medical device regulation.

Every FDA decision can spark a market revolution. From surprise approvals of groundbreaking therapies to unexpected rejections that send stocks tumbling, our feed captures it all.

Turn regulatory news into your competitive edge. With our real-time updates on FDA decisions, you're not just watching the biotech market 鈥� you're anticipating its next move.

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AMRX : Nasdaq
Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution
fda approval
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WALD : Nasdaq
Waldencast Announces FDA Approval of Obagi庐 saypha庐 MagIQ鈩� Injectable Hyaluronic Acid Gel Under the Obagi Medical Brand
fda approval penny stock
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JNJ : NYSE
U.S. FDA approval of INLEXZO鈩� (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
fda approval
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TAK : NYSE
U.S. FDA Approves Expanded Indication for VONVENDI庐 [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease
fda approval
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CLPT : Nasdaq
ClearPoint Neuro Announces FDA Clearance Expanding Compatibility of the ClearPoint Prism Neuro Laser Therapy System with 1.5T MRI Scanners
clinical trial fda approval
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AMRX : Nasdaq
Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension
fda approval
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MDT : NYSE
FDA Clears MiniMed鈩� 780G System to Enable Integration with the Instinct Sensor, Made by Abbott, and Approves Use in Type 2 Diabetes
fda approval
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OGN : NYSE
US Food and Drug Administration (FDA) Approves Henlius and Organon鈥檚 BILDYOS庐 (denosumab-nxxp) and BILPREVDA庐 (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively
fda approval
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BIOA : Nasdaq
US FDA approves Leqembi庐 IQKLIK 鈩� (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease
fda approval
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BIIB : Nasdaq
FDA Approves LEQEMBI庐 IQLIK鈩� (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
fda approval
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TEVA : NYSE
Teva Announces FDA Approval and Launch of Generic Saxenda庐 (liraglutide injection) 鈥� First Generic GLP-1 Indicated for Weight Loss
clinical trial fda approval
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VNDA : Nasdaq
Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation for VGT-1849B, a Novel and Selective Candidate for the Treatment of Polycythemia Vera
clinical trial fda approval
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TVTX : Nasdaq
Travere Therapeutics Announces U.S. FDA Approves REMS Modification for FILSPARI庐 (sparsentan) in IgA Nephropathy
fda approval
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MRNA : Nasdaq
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2
fda approval covid-19
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BNTX : Nasdaq
Pfizer and BioNTech鈥檚 COMIRNATY庐 Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19
fda approval covid-19
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PHRRF : OTC
PharmaTher Advances Ketamine Patch as Non-Opioid Pain Relief Solution Leveraging FDA Approved IV Ketamine (KETARx(TM)), Aligned with FDA's CNPV National Priority Initiative
fda approval penny stock
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PHRRF : OTC
PharmaTher Provides Corporate Update Following FDA Approval of Ketamine (KETARx鈩�)
fda approval penny stock
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DGX : NYSE
FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics
fda approval
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A : NYSE
Agilent MMR IHC Panel pharmDx (Dako Omnis) Receives FDA Approval as a Companion Diagnostic Test for Colorectal Cancer
fda approval
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MASI : Nasdaq
Masimo O3庐 Regional Oximetry Receives FDA Clearance for Expanded Indication of Its Unique Delta Hemoglobin Parameters
clinical trial fda approval
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IRD : Nasdaq
Opus Genetics Announces FDA Clearance of IND Application for Gene Therapy Candidate OPGx-BEST1
clinical trial fda approval penny stock
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SNGX : Nasdaq
FDA Grants Soligenix Orphan Drug Designation for the Treatment of Beh莽et's Disease after Reviewing Recent Phase 2 Clinical Study Results
clinical trial fda approval low float
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TNXP : Nasdaq
Tonix Pharmaceuticals Announces FDA Approval of Tonmya鈩⒙�(cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia
fda approval low float
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PGEN : Nasdaq
Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
fda approval
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PHRRF : OTC
PharmaTher Founder and CEO Issues Letter to Shareholders following the FDA Approval of Ketamine (KETARx鈩�)
fda approval penny stock
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Today's News - Full List