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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
VRTX : Nasdaq
Vertex Announces US FDA Approval for Label Extensions of ALYFTREK® and TRIKAFTA®, Expanding Availability of These Medicines to ~95% of All People With CF in the United States
fda approval
IMPACT
SENTIMENT
CRBU : Nasdaq
Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy
fda approval penny stock
IMPACT
SENTIMENT
HAE : NYSE
Haemonetics Receives FDA Approval for Expanded Labeling of the VASCADE MVP® XL Venous Vascular Closure System
fda approval
IMPACT
SENTIMENT
AKTS : Nasdaq
Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results
earnings clinical trial fda approval low float
IMPACT
SENTIMENT
RARE : Nasdaq
Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy
clinical trial fda approval
IMPACT
SENTIMENT
BFLY : NYSE
Butterfly Network Secures First FDA Clearance for Blind Sweep Ultrasound AI Tool, Marking a Major Stride for Women’s Health
clinical trial fda approval AI
IMPACT
SENTIMENT
TEVA : NYSE
Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)
fda approval
IMPACT
SENTIMENT
BIIB : Nasdaq
FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy
fda approval
IMPACT
SENTIMENT
BSX : NYSE
Boston Scientific receives FDA clearance for the Asurys™ Fluid Management System
clinical trial fda approval
IMPACT
SENTIMENT
MDT : NYSE
Medtronic Receives FDA Clearance for Stealth AXiS™ Surgical System for Cranial and ENT Procedures
clinical trial fda approval
IMPACT
SENTIMENT
SPRY : Nasdaq
ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label
fda approval high short
IMPACT
SENTIMENT
LTRN : Nasdaq
Lantern Pharma and Starlight Therapeutics Announce FDA Clearance of IND for a Planned Phase 1 Pediatric CNS Cancer Trial of STAR-001
clinical trial fda approval low float penny stock
IMPACT
SENTIMENT
RCKT : Nasdaq
Rocket Pharmaceuticals Announces FDA Approval of KRESLADI™ for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I)
fda approval
IMPACT
SENTIMENT
PHG : NYSE
FDA clears Philips AI solution that provides real-time guidance during complex minimally invasive heart valve repair
fda approval AI
IMPACT
SENTIMENT
A : NYSE
Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma
fda approval
IMPACT
SENTIMENT
BWAY : Nasdaq
BrainsWay Completes Additional $6 Million Milestone-Based Investment in Neurolief Ltd. Following FDA Approval of Proliv™Rx System for MDD
fda approval
IMPACT
SENTIMENT
KMDA : Nasdaq
Kamada Announces FDA Approval of its Plasma Collection Center in San Antonio, Texas
fda approval
IMPACT
SENTIMENT
CORT : Nasdaq
FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer
fda approval
IMPACT
SENTIMENT
DNLI : Nasdaq
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
fda approval
IMPACT
SENTIMENT
GEHC : Nasdaq
GE HealthCare’s Photonova Spectra photon-counting CT receives FDA clearance
clinical trial fda approval
IMPACT
SENTIMENT
MDT : NYSE
Medtronic OmniaSecure™ defibrillation lead is the first lead of its kind to receive FDA approval for conduction system pacing
fda approval
IMPACT
SENTIMENT
RYTM : Nasdaq
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
acquisition fda approval
IMPACT
SENTIMENT
NVO : NYSE
FDA approves Novo Nordisk's new Wegovy® HD injection, delivering the highest weight loss to date for a Wegovy® injection, adding to its already expansive clinical profile
fda approval
IMPACT
SENTIMENT
LIVN : Nasdaq
LivaNova Receives U.S. Food and Drug Administration Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea
fda approval
IMPACT
SENTIMENT
MRK : NYSE
FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs
fda approval
IMPACT
SENTIMENT
MMED : Nasdaq
MiniMed Announces FDA Clearance of MiniMed Flex™, the Company's Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design
clinical trial fda approval
IMPACT
SENTIMENT
PTGX : Nasdaq
Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis
fda approval
IMPACT
SENTIMENT
JNJ : NYSE
FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide
fda approval
IMPACT
SENTIMENT
MYGN : Nasdaq
Myriad Genetics Receives FDA Approval of the MyChoice CDx Test as the Companion Diagnostic for Zejula (niraparib) for Patients with Ovarian Cancer 
fda approval
IMPACT
SENTIMENT
JNJ : NYSE
Johnson & Johnson Announces FDA Approval of TECNIS PureSee Intraocular Lens, a Breakthrough Solution for U.S. Cataract Patients
fda approval
IMPACT
SENTIMENT
ICCM : Nasdaq
U.S. FDA Approves IceCure's Post-Marketing "ChoICE" Study for ProSense® Cryoablation in the Local Treatment of Low-Risk Breast Cancer
fda approval penny stock
IMPACT
SENTIMENT
QNRX : Nasdaq
Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome
clinical trial fda approval low float
IMPACT
SENTIMENT
QTI : Nasdaq
QT Imaging Receives FDA Clearance for Its Breast Acoustic CT Scanner Enhanced Configuration to Improve Posterior Breast Imaging Coverage
clinical trial fda approval low float
IMPACT
SENTIMENT
BMY : NYSE
U.S. FDA Approves Bristol Myers Squibb’s Sotyktu® (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis
fda approval
IMPACT
SENTIMENT
LNTH : Nasdaq
Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection
fda approval
IMPACT
SENTIMENT
HALO : Nasdaq
U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma
fda approval
IMPACT
SENTIMENT
ALLR : Nasdaq
Allarity Therapeutics Closes $20 Million Financing to Accelerate the Advance of Stenoparib Toward FDA Approval and Commercialization
fda approval low float penny stock
IMPACT
SENTIMENT
JNJ : NYSE
Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
offering fda approval
IMPACT
SENTIMENT
VCEL : Nasdaq
Vericel Announces FDA Approval of New State-of-the-Art Advanced Therapy Manufacturing Facility
fda approval
IMPACT
SENTIMENT
VNDA : Nasdaq
Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years
fda approval
IMPACT
SENTIMENT
TAK : NYSE PTGX : Nasdaq
Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera
clinical trial fda approval
IMPACT
SENTIMENT
BMRN : Nasdaq
U.S. Food and Drug Administration Approves BioMarin's PALYNZIQ® (pegvaliase-pqpz) for Adolescents 12 Years of Age and Older with Phenylketonuria (PKU)
fda approval
IMPACT
SENTIMENT
ASND : Nasdaq
FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older
fda approval
IMPACT
SENTIMENT
TCRX : Nasdaq
TScan Therapeutics Completes Enrollment in Cohort C of Phase 1 ALLOHA™ Trial and Announces FDA Clearance of Investigational New Drug Applications for Heme Candidates TSC-102-A01 and TSC-102-A03
clinical trial fda approval penny stock
IMPACT
SENTIMENT
MRK : NYSE
FDA Approves NUMELVI™ (atinvicitinib tablets) for Dogs from Merck Animal Health – The First and Only Second-Generation Janus Kinase (JAK) Inhibitor for the Control of Pruritus Associated with Allergic Dermatitis
fda approval
IMPACT
SENTIMENT
ETON : Nasdaq
Eton Pharmaceuticals Announces U.S. FDA Approval for DESMODA™ (desmopressin acetate) Oral Solution
fda approval
IMPACT
SENTIMENT
JNJ : NYSE
Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
fda approval
IMPACT
SENTIMENT
PFE : NYSE
U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer
fda approval
IMPACT
SENTIMENT
AMPH : Nasdaq
Amphastar Announces FDA Approval for Ipratropium Bromide HFA
fda approval
IMPACT
SENTIMENT
HAE : NYSE
Haemonetics Receives FDA Clearance for NexSys® PCS Plasma Collection System with Persona® PLUS Technology
clinical trial fda approval
Today's News - Full List