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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 – you're anticipating its next move.

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JAZZ : Nasdaq
Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
fda approval
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MDT : NYSE
Medtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM
clinical trial fda approval
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UCBJY : OTC
UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa
fda approval
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SGMO : Nasdaq
Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain
clinical trial fda approval penny stock
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NVNO : Nasdaq
enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval
fda approval low float
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MDAI : Nasdaq MDAIW : Nasdaq
Spectral AI Raises Up to $5 Million Financing Strengthening Financial Position for FDA Pathway
fda approval AI low float penny stock
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PHRRF : OTC
PharmaTher Announces Update on FDA New Drug Application for Ketamine
fda approval penny stock
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GORV : Nasdaq
LAZYDAYS REPORTS THIRD QUARTER 2024 RESULTS
earnings
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ISPR : Nasdaq
IKE Tech LLC and Ispire Technology Inc. Announce Positive Pre-PMTA Submission Meeting with the FDA
fda approval low float
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CTNM : Nasdaq
Contineum Therapeutics Expands Clinical Development of PIPE-791 With FDA Authorization of Its Investigational New Drug (IND) Application for Chronic Pain
clinical trial fda approval low float
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ARWR : Nasdaq
Arrowhead Pharmaceuticals Submits New Drug Application to U.S. FDA for Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
fda approval
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ALDX : Nasdaq
Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option Agreement
clinical trial fda approval
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ELTP : OTC
Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse
fda approval penny stock
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SNDX : Nasdaq
Syndax Announces FDA Approval of Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation
fda approval
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CERO : Nasdaq
CERo Therapeutics, Inc. Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Its Lead Compound CER-1236 in Acute Myelogenous Leukemia
clinical trial fda approval penny stock
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PTCT : Nasdaq
PTC Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy
fda approval
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CLPT : Nasdaq
ClearPoint Neuro Announces FDA De Novo Marketing Authorization of SmartFlow Cannula for Direct Delivery of Gene Therapy to the Brain
fda approval
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CELZ : OTC
Creative Medical Technology Holdings, Inc. Advances FDA Cleared ADAPT Clinical Trial with Positive Independent Review, Validating the Safety and Potential of CELZ-201 for Chronic Lower Back Pain Treatment
clinical trial fda approval low float
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INBS : Nasdaq
Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
fda approval low float penny stock
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SLP : Nasdaq
Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables
fda approval low float
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GEHC : Nasdaq
GE HealthCare Receives FDA Clearance for Head-Only SIGNA MAGNUS 3.0T MRI System
clinical trial fda approval
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PHRRF : OTC
PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
fda approval penny stock
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PHG : NYSE
Philips Spectral CT 7500 RT, world’s first spectral 4DCT respiratory-gated imaging receives FDA 510(k) clearance
clinical trial fda approval
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ACTU : Nasdaq
Actuate Announces FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma
fda approval low float
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ICAD : Nasdaq
iCAD's ProFound Detection Version 4.0 Gains FDA Clearance
clinical trial fda approval penny stock
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TPST : Nasdaq
Tempest Receives FDA Study May Proceed for Pivotal Phase 3 Trial of Amezalpat Combination Therapy for the Treatment of First-Line Hepatocellular Carcinoma
clinical trial fda approval penny stock
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PROK : Nasdaq
ProKidney Reports Third Quarter 2024 Financial Results along with Regulatory and Clinical Development Updates Following Successful FDA Type B Meeting
earnings clinical trial fda approval penny stock
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ABEO : Nasdaq
Abeona Therapeutics® Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
clinical trial fda approval
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PM : NYSE
FDA Reauthorizes Swedish Match’s General snus as a Modified Risk Tobacco Product
fda approval
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SNOA : Nasdaq
Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care Hydrogel
clinical trial fda approval low float
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JNJ : NYSE
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease
fda approval
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ARCT : Nasdaq
Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
clinical trial fda approval
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NVAX : Nasdaq
U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial
clinical trial fda approval covid-19 high short
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RAPT : Nasdaq
Based on Recent FDA Feedback RAPT Therapeutics Stops Zelnecirnon Program Following Clinical Hold Due to Single SAE of Severe Liver Injury
fda approval penny stock
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UNCY : Nasdaq
Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
clinical trial fda approval penny stock
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AUTL : Nasdaq
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
fda approval
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ICCM : Nasdaq
FDA Advisory Panel Votes in Favor of IceCure's ProSense® Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
fda approval penny stock
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MBIO : Nasdaq
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma
clinical trial fda approval penny stock
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CVM : NYSE
U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025
earnings fda approval penny stock
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ALT : Nasdaq
Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity
clinical trial fda approval high short
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CPIX : Nasdaq
CUMBERLAND PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG AND RARE PEDIATRIC DISEASE DESIGNATIONS FOR NEW TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
fda approval low float penny stock
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JAGX : Nasdaq
FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea in Dogs
fda approval low float penny stock
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ICU : Nasdaq
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
fda approval low float
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OGN : NYSE
Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older
fda approval
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MRUS : Nasdaq
Merus Receives FDA extension of PDUFA for zenocutuzumab
fda approval
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NPCE : Nasdaq
NeuroPace Announces FDA Submission of Three-Year Data from Post-Approval Study of the RNS System in Focal Epilepsy
fda approval
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PHXM : Nasdaq
PHAXIAM Therapeutics Receives FDA Clearance to Initiate Phase II GLORIA Study in the U.S.
clinical trial fda approval low float
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IONS : Nasdaq
Ionis announces FDA acceptance of New Drug Application for donidalorsen for prophylactic treatment of HAE
clinical trial fda approval
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NRXS : NYSE
NeurAxis Receives New FDA 510(K) Clearance for IB-Stim, Expanding its Addressable Market
clinical trial fda approval low float
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CYDY : OTC
CytoDyn Announces FDA Clearance of Its Phase II Oncology Trial
clinical trial fda approval penny stock
Today's News - Full List