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FDA Approval News Today | Live Drug Approvals News Tracker ⏲ DELAYED 2 Min

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Track FDA drug approvals and rejections as they happen. FDA decisions are among the most impactful catalysts for biotech and pharmaceutical stocks, often triggering significant price movements.

Our AI-powered feed analyzes each FDA announcement for market impact, providing real-time sentiment analysis. Gold members receive instant alerts when major FDA decisions are announced.

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IMPACT
SENTIMENT
VERA : Nasdaq
Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy
fda approval
IMPACT
SENTIMENT
BTAI : Nasdaq
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®
fda approval high short
IMPACT
SENTIMENT
STXS : NYSE
Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter
fda approval
IMPACT
SENTIMENT
JAGX : Nasdaq
Jaguar Health Awarded $240,000 FDA Grant in Support of Canalevia-CA1 for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs
fda approval low float penny stock
IMPACT
SENTIMENT
VNDA : Nasdaq
Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness
fda approval
IMPACT
SENTIMENT
PRAX : Nasdaq
Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor
fda approval
IMPACT
SENTIMENT
OMER : Nasdaq
FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA
fda approval
IMPACT
SENTIMENT
AGIO : Nasdaq
U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia
fda approval
IMPACT
SENTIMENT
EW : NYSE
FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
fda approval
IMPACT
SENTIMENT
AMRX : Nasdaq
Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®
fda approval
IMPACT
SENTIMENT
ABT : NYSE
Abbott's Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation
fda approval
IMPACT
SENTIMENT
RHHBY : OTC
FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma
fda approval
IMPACT
SENTIMENT
RHHBY : OTC
FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma
fda approval
IMPACT
SENTIMENT
CYTK : Nasdaq
Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
fda approval
IMPACT
SENTIMENT
FEMY : Nasdaq
Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device
clinical trial fda approval penny stock
IMPACT
SENTIMENT
ABT : NYSE
Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for Premature Babies With a Hole in the Heart
clinical trial fda approval
IMPACT
SENTIMENT
BFRI : Nasdaq BFRIW : Nasdaq
Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio
fda approval low float penny stock
IMPACT
SENTIMENT
JNJ : NYSE
Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma
fda approval
IMPACT
SENTIMENT
HALO : Nasdaq
U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer
fda approval
IMPACT
SENTIMENT
JNJ : NYSE
U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE® (lazertinib)
fda approval
IMPACT
SENTIMENT
ICCM : Nasdaq
IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer
earnings date clinical trial fda approval penny stock
IMPACT
SENTIMENT
VATE : NYSE
MediBeacon® Next Generation TGFR™ System Receives FDA Approval
fda approval low float
IMPACT
SENTIMENT
HYPR : Nasdaq
Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop® System
clinical trial fda approval AI penny stock
IMPACT
SENTIMENT
AMPH : Nasdaq
Amphastar Announces FDA Approval for Teriparatide Injection
fda approval
IMPACT
SENTIMENT
JNJ : NYSE
U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care*
fda approval
IMPACT
SENTIMENT
MIST : Nasdaq
Milestone Receives FDA Approval of CARDAMYST™ (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)
fda approval
IMPACT
SENTIMENT
INVA : Nasdaq
U.S. FDA Approves NUZOLVENCE® (zoliflodacin), a First-in-Class, Single-dose, Oral Antibiotic for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents
fda approval
IMPACT
SENTIMENT
EBS : NYSE
Emergent BioSolutions Receives U.S. FDA Approval for Drug Product Manufacturing of raxibacumab at its Winnipeg, Canada Site
fda approval
IMPACT
SENTIMENT
ACAD : Nasdaq
Acadia Pharmaceuticals Announces FDA Approval of DAYBUE® STIX (trofinetide) for Oral Solution, a New Powder Formulation of Trofinetide for the Treatment of Rett Syndrome
fda approval
IMPACT
SENTIMENT
BCRX : Nasdaq
BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years
fda approval
IMPACT
SENTIMENT
AMGN : Nasdaq
FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS
fda approval
IMPACT
SENTIMENT
BMY : NYSE
U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma
fda approval
IMPACT
SENTIMENT
JAGX : Nasdaq
FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea (CID) in Dogs
fda approval low float penny stock
IMPACT
SENTIMENT
BEAT : Nasdaq
HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment
clinical trial fda approval
IMPACT
SENTIMENT
AMRX : Nasdaq
Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals
fda approval
IMPACT
SENTIMENT
B : Nasdaq CRNO : Nasdaq
Cereno Scientific Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)
clinical trial fda approval
IMPACT
SENTIMENT
RMD : NYSE
Resmed Receives FDA Clearance for Personalized Therapy Comfort Settings, to be Marketed as Smart Comfort, an AI-Enabled, Digital Medical Device That Helps Personalize CPAP Therapy
clinical trial fda approval AI
IMPACT
SENTIMENT
HIND : Nasdaq
Vyome Reports Positive Final Phase 2 Results for VT-1953; Plans to Advance Into Pivotal Study For FDA Approval
clinical trial fda approval low float
IMPACT
SENTIMENT
AXGN : Nasdaq
Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)
fda approval
IMPACT
SENTIMENT
MDT : NYSE
Medtronic announces FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures
clinical trial fda approval
IMPACT
SENTIMENT
LLY : NYSE
U.S. FDA approves expanded indication for Lilly's Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor
fda approval
IMPACT
SENTIMENT
DRTS : Nasdaq DRTSW : Nasdaq
Alpha Tau Receives FDA Approval to Initiate a Trial for Patients with Locally Recurrent Prostate Cancer
fda approval
IMPACT
SENTIMENT
ICU : Nasdaq
SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI
fda approval low float
IMPACT
SENTIMENT
AMRX : Nasdaq
Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol
fda approval
IMPACT
SENTIMENT
RHHBY : OTC
Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)
clinical trial fda approval
IMPACT
SENTIMENT
AMRX : Nasdaq
Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05%
fda approval
IMPACT
SENTIMENT
ONC : Nasdaq
U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
fda approval
IMPACT
SENTIMENT
NRSN : Nasdaq
NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS
clinical trial fda approval penny stock
IMPACT
SENTIMENT
MRK : NYSE
FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults with Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
fda approval
IMPACT
SENTIMENT
PFE : NYSE
U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer
fda approval
Today's News - Full List