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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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IMPACT
SENTIMENT
CLLS : Nasdaq
FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to Cellectis’ UCART22 product candidate for Acute Lymphoblastic Leukemia (ALL) Treatment
fda approval
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ATNM : NYSE NYSE : NYSE
Actinium Announces FDA Clearance of Iomab-ACT Targeted Conditioning IND Application for Sickle Cell Disease Patients Undergoing Bone Marrow Transplant in Collaboration with Columbia University
clinical trial fda approval
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TNXP : Nasdaq
Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia
clinical trial fda approval low float high short
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CKPT : Nasdaq FBIO : Nasdaq
Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma
clinical trial fda approval
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ACIU : Nasdaq
AC Immune’s ACI-35.030 (now “JNJ-2056”) Granted FDA Fast Track Designation for Alzheimer’s Disease
clinical trial fda approval
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AMIX : Nasdaq
Autonomix Completes Licensing Transaction for FDA-Cleared Ablation Technology
fda approval low float
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NTBL : Nasdaq
Notable Labs Receives FDA Clearance to Proceed Further with Volasertib Phase 2 Study
clinical trial fda approval low float
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TLSA : Nasdaq
Tiziana Life Sciences Granted FDA Fast Track Designation
clinical trial fda approval
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KNBIF : OTC
Kane Biotech Receives FDA Approval to Increase Dosage Allowance of its revyve™ Antimicrobial Wound Gel
fda approval
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ICU : Nasdaq
First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical’s FDA-Approved QUELIMMUNE Therapeutic Device
fda approval low float
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ANIX : Nasdaq
Anixa Biosciences Announces FDA Approval of Individual Patient IND for its Ovarian Cancer CAR-T Therapy
fda approval
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ZIMV : Nasdaq
ZimVie Announces FDA Clearance and U.S. Launch of GenTek® Restorative Components
clinical trial fda approval
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SENTIMENT
BCAB : Nasdaq
BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
clinical trial fda approval
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SENTIMENT
ARQT : Nasdaq
Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
fda approval high short
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SENTIMENT
MESO : Nasdaq
FDA Accepts Mesoblast’s Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
clinical trial fda approval
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ASXC : NYSE
Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology
clinical trial fda approval
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IMMP : Nasdaq
Immutep Announces Successful Meeting with FDA on Phase III Design in Non-Small Cell Lung Cancer
clinical trial fda approval
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ARQT : Nasdaq
Arcutis to Host ZORYVE® (Roflumilast) Cream 0.15% FDA Approval Call With KOL
conferences fda approval high short
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JNJ : NYSE
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
fda approval
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SENTIMENT
ZYME : Nasdaq
Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW191, a Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate
clinical trial fda approval
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NGVC : NYSE
Natural Grocers® Issues Statement Supporting FDA's Recent Ruling Against the Use of Brominated Vegetable Oil in Food
fda approval
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SENTIMENT
NXGL : Nasdaq NXGLW : Nasdaq
NEXGEL and Innovative Optics US Initiate Institutional Review Board (IRB) Study in Accordance with FDA of Hydrogel Application During Laser Hair Removal
fda approval low float
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INBS : Nasdaq
Intelligent Bio Solutions Inc. Advances on FDA 510(k) Pathway with Biocompatibility Study Success
fda approval low float
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PHAT : Nasdaq
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults
fda approval high short
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RARE : Nasdaq
Ultragenyx Announces Successful End-of-Phase 2 Meeting with FDA for GTX-102 Angelman Syndrome Program
clinical trial fda approval
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ATRA : Nasdaq
Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
clinical trial fda approval low float
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HYPR : Nasdaq
Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images
acquisition clinical trial fda approval
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GMED : NYSE
Globus Medical Receives FDA 510(k) Clearance for ExcelsiusFlex™ and ACTIFY™ 3D Total Knee System
clinical trial fda approval
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INMD : Nasdaq
Morpheus8 Secures First and Only FDA Clearance for Soft Tissue Contraction for Fractional Radiofrequency Microneedling
clinical trial fda approval
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LGVN : Nasdaq LGVNR : Nasdaq
Longeveron® Announces U.S. FDA Grants Fast Track Designation for Lomecel-B™ for the Treatment of Mild Alzheimer’s Disease
clinical trial fda approval low float high short
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SLS : Nasdaq
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
fda approval
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CMND : Nasdaq
Clearmind Medicine Obtains IND Approval from the FDA to Start the Phase I/IIa Clinical Trial with its Innovative Treatment for Alcoholism
clinical trial fda approval low float
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THAR : Nasdaq
Tharimmune Launches New Website as Discussions with FDA Continue for Phase 2 Clinical Trial with TH104
clinical trial fda approval low float
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ANVS : NYSE
Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap
fda approval low float
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PASG : Nasdaq
Passage Bio Announces Positive Feedback from FDA on Expansion of upliFT-D Trial of PBFT02 to Include FTD-C9orf72 Patients
fda approval
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KNOS : OTC
Kronos Advanced Technologies Inc. Warns Consumers to Use Only FDA-Cleared Air Purifiers at Home and Office
fda approval
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ETON : Nasdaq
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
clinical trial fda approval
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KYTX : Nasdaq
Kyverna's KYV-101 Receives U.S. FDA RMAT Designation for KYV-101 in the Treatment of Patients With Refractory Stiff-Person Syndrome
fda approval
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ARTL : Nasdaq
Artelo Biosciences Receives FDA Clearance of its IND Application for ART26.12, a Selective Fatty Acid Binding Protein 5 Inhibitor
clinical trial fda approval low float
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AMIX : Nasdaq
Autonomix Enters into Definitive Agreement to License Intellectual Property for FDA-Cleared Ablation Technology from RF Innovations, Inc.
fda approval low float
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ANIP : Nasdaq
ANI Pharmaceuticals Announces the FDA Approval and Launch of L-Glutamine Oral Powder
fda approval
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EMMA : OTC
Emmaus Life Sciences Announces Outcome of FDA Inspection of Postmarketing Adverse Drug Experience Compliance Program
fda approval
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ABBV : NYSE
AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Giant Cell Arteritis
fda approval
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CLNN : Nasdaq
Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA Feedback on Potential Pathway to Accelerated Approval for CNM-Au8® in ALS
fda approval low float
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CANF : NYSE
Can-Fite Applies for FDA Orphan Drug Designation for Namodenoson in the Treatment of Pancreatic Cancer
clinical trial fda approval
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BPTS : Nasdaq
Biophytis Obtains IND Approval from the FDA to Start its Phase 2 OBA Study in Obesity
clinical trial fda approval
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MBRX : Nasdaq
Moleculin Completes End of Phase 2 Meeting with FDA for Annamycin in AML
clinical trial fda approval low float
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LGVN : Nasdaq LGVNR : Nasdaq
Longeveron® Announces U.S. FDA Grants Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer’s Disease
fda approval low float high short
IMPACT
SENTIMENT
AMLX : Nasdaq
Amylyx Pharmaceuticals Announces Acquisition of Phase 3-ready GLP-1 Receptor Antagonist (Avexitide) with FDA Breakthrough Therapy Designation
acquisition clinical trial fda approval
IMPACT
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KNOS : OTC
FDA Greenlights Second Model in Kronos Advanced Technologies Inc.'s Revolutionary Air Purifiers Line
fda approval
Today's News - Full List