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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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RCEL : Nasdaq
AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for Smaller Wounds
fda approval
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TNXP : Nasdaq
Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia
fda approval penny stock
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GKOS : NYSE
Glaukos Submits New Drug Application to U.S. FDA for Epioxa™
fda approval
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LLY : NYSE
FDA approves Zepbound® (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity
fda approval
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VRTX : Nasdaq
Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis
fda approval
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VRTX : Nasdaq
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants
fda approval
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RYTM : Nasdaq
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old
fda approval
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PFE : NYSE
U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
fda approval
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MMSI : Nasdaq
Merit Medical Announces FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis
fda approval
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HUMA : Nasdaq
Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma
fda approval
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RCEL : Nasdaq
AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
clinical trial fda approval
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MIRA : Nasdaq
MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development
fda approval low float penny stock
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IMNN : Nasdaq
IMUNON Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer
fda approval low float penny stock
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RARE : Nasdaq
Ultragenyx Submits Biologics License Application to the U.S. FDA for UX111 AAV Gene Therapy for the Treatment of Sanfilippo Syndrome Type A (MPS IIIA)
fda approval
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IRD : Nasdaq
Opus Genetics Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Trial of APX3330 in Diabetic Retinopathy
clinical trial fda approval penny stock
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PLUR : Nasdaq
Pluri Congratulates Mesoblast on FDA Approval of First Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease
fda approval low float
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AQST : Nasdaq
Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five
fda approval
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QNRX : Nasdaq
Quoin Pharmaceuticals Announces FDA Clearance to Initiate New QRX003 Netherton Syndrome Clinical Study
clinical trial fda approval low float penny stock
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PTCT : Nasdaq
PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia
fda approval
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NLSP : Nasdaq
NLS Pharmaceutics and Kadimastem Announce the Submission of a Request by Kadimastem and iTolerance, Inc. for an FDA Pre-IND Meeting for an Innovative Breakthrough Type 1 Diabetes Treatment
fda approval low float penny stock
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NRIX : Nasdaq
Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia
clinical trial fda approval
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MESO : Nasdaq
Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy
fda approval
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SVRA : Nasdaq
Savara Initiates Rolling Submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
fda approval
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THTX : Nasdaq
Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment
fda approval penny stock
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MGRM : Nasdaq
Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA
fda approval
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INBS : Nasdaq
Intelligent Bio Solutions Announces 510(k) Submission to US FDA for Fingerprint Sweat-Based Drug Screening Technology
fda approval low float penny stock
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LLY : NYSE
Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of the IND application for the innovative Bi-weekly GLP-1RA GZR18 Injection, Bofanglutide, with chronic weight management Indication (A Phase 2 head-to-head with Tirzepatide clinical trial)
clinical trial fda approval
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GELS : Nasdaq
Gelteq Receives FDA Approval of its Suitability Petition for New Animal Drug
fda approval low float
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GILD : Nasdaq
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer
fda approval
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JAGX : Nasdaq
FDA Approves Orphan-Drug Designation for Jaguar Health’s Crofelemer for Treatment of Diarrhea in Cholera
fda approval low float penny stock
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TNXP : Nasdaq
Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
clinical trial fda approval penny stock
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LPCN : Nasdaq
FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis
clinical trial fda approval low float
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MRK : NYSE
Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season
clinical trial fda approval
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DRMA : Nasdaq DRMAW : Nasdaq
Dermata Receives Approval from FDA for the Proprietary Name Xyngari(TM)
fda approval low float penny stock
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MAIA : NYSE
MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation for THIO as a Treatment for Pediatric High-Grade Gliomas
fda approval penny stock
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BEAT : Nasdaq
HeartBeam Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology
clinical trial fda approval low float
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ARQT : Nasdaq
Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis
fda approval high short
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OGN : NYSE
FDA Approves 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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NBIX : Nasdaq
Neurocrine Biosciences Announces FDA Approval of CRENESSITY™ (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia
fda approval
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CKPT : Nasdaq FBIO : Nasdaq
Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)
fda approval
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ZBH : NYSE
Zimmer Biomet Receives FDA Clearance for OsseoFit™ Stemless Shoulder System for Total Shoulder Replacement
clinical trial fda approval
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VIR : Nasdaq
Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta
fda approval
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ASND : Nasdaq
FDA Accepts Ascendis Pharma’s Supplemental Biologics License Application for TransCon™ hGH for the Treatment of Adults with Growth Hormone Deficiency
clinical trial fda approval
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IMRX : Nasdaq
Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma
clinical trial fda approval
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MDCX : Nasdaq
Medicus Pharma Ltd. Announces Minor Use (MUMS) Designation from the FDA for Doxorubicin-Containing Microneedle Array (D-MNA) Patch
fda approval low float
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DBVT : Nasdaq
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
fda approval low float
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NRSN : Nasdaq
NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC
clinical trial fda approval low float penny stock
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PHAT : Nasdaq
Phathom Pharmaceuticals Submits Citizen Petition to FDA Seeking Correction of Orange Book Listings for VOQUEZNA® (vonoprazan) Tablets
fda approval high short
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NRXS : NYSE
NeurAxis Inc. Announces FDA 510(k) Clearance of RED for Testing and Evaluation of Patients with Chronic Constipation
clinical trial fda approval low float
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CLNN : Nasdaq
FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS
fda approval low float
Today's News - Full List