STOCK TITAN

Notifications

Limited Time Offer! Get Platinum at the Gold price until January 31, 2026!

Sign up now and unlock all premium features at an incredible discount.

Read more on the Pricing page

  1. Home
  2. News
  3. FDA Approvals Today

FDA Drug Approvals & Biotech News LIVE

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.

Pair with our momentum scanner to catch price swings. Also see: Clinical Trials News.

615

NEWS
TODAY
check them out

23

NEWS ENHANCED BY
RHEA-AI
Who is Rhea? Read More
NEWS BY EXCHANGE
NYSE Nasdaq OTC

Stock News Live Feed

Today's News - Full List
No News Found

No news articles match your current filters.

Try adjusting your filter settings or check back later.

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 penny stock
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
IMPACT
SENTIMENT
BAYRY : OTC BAYZF : OTC
U.S. FDA Approves HYRNUO® (sevabertinib) for Previously Treated Patients with HER2-Mutated Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
fda approval
IMPACT
SENTIMENT
AMGN : Nasdaq
FDA GRANTS FULL APPROVAL TO AMGEN'S IMDELLTRA® IN EXTENSIVE STAGE SMALL CELL LUNG CANCER
fda approval
IMPACT
SENTIMENT
DXCM : Nasdaq
Dexcom Smart Basal Receives FDA Clearance Becoming the First and Only CGM-integrated Basal Insulin Dosing Optimizer for Type 2 Diabetes
clinical trial fda approval
IMPACT
SENTIMENT
ABBV : NYSE
AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma
fda approval
IMPACT
SENTIMENT
ARWR : Nasdaq
Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)
fda approval
IMPACT
SENTIMENT
EBS : NYSE
Emergent BioSolutions Marks 10-Year Anniversary of the U.S. FDA Approval of NARCAN® Nasal Spray and Reinforces its Commitment to Increasing Naloxone Access
fda approval
IMPACT
SENTIMENT
OGN : NYSE
Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US
fda approval
IMPACT
SENTIMENT
ZBH : NYSE
Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology
clinical trial fda approval
IMPACT
SENTIMENT
AMRX : Nasdaq
Amneal Receives U.S. FDA Approval for Iohexol Injection
fda approval
IMPACT
SENTIMENT
KURA : Nasdaq
Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
fda approval
IMPACT
SENTIMENT
SINT : Nasdaq
SINTX Reports Pivotal Third Quarter Business Update and Financial Highlights Driven by FDA Clearance, Product and IP Portfolio Expansions and Increased Operational Efficiencies
clinical trial fda approval low float
IMPACT
SENTIMENT
BWAY : Nasdaq
BrainsWay Receives FDA Clearance of Deep TMS™ as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21
clinical trial fda approval low float
IMPACT
SENTIMENT
ELTP : OTC
Elite Pharmaceuticals Receives FDA Approval for Generic Requip XL(R)
fda approval penny stock
IMPACT
SENTIMENT
STXS : NYSE
GenesisX Robotic Magnetic Navigation System Receives U.S. FDA Clearance
clinical trial fda approval
IMPACT
SENTIMENT
TNDM : Nasdaq
Tandem Mobi Receives FDA Clearance for Use with Android Smartphones
clinical trial fda approval
IMPACT
SENTIMENT
IPHA : Nasdaq
Innate Pharma Announces FDA Clearance to Proceed With TELLOMAK 3, a Confirmatory Phase 3 Trial of Lacutamab in CTCL
clinical trial fda approval penny stock
IMPACT
SENTIMENT
HALO : Nasdaq
FDA Approved DARZALEX Faspro® for Adult Patients with High-Risk Smoldering Multiple Myeloma
fda approval
IMPACT
SENTIMENT
JNJ : NYSE
FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
fda approval
IMPACT
SENTIMENT
JUNS : Nasdaq
Jupiter Neurosciences Receives FDA Clearance of IND Application to Initiate Phase 2a Clinical Trial of JOTROL™ in Parkinson’s Disease
clinical trial fda approval low float penny stock
IMPACT
SENTIMENT
FEMY : Nasdaq
Femasys Secures FDA Approval to Advance Final FemBloc® Trial Phase and $12 Million Financing, with Potential to Reach $58 Million
fda approval penny stock
IMPACT
SENTIMENT
RNTX : Nasdaq
Rein Therapeutics Receives FDA Clearance to Resume U.S. Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
clinical trial fda approval penny stock
IMPACT
SENTIMENT
AVR : Nasdaq
FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
fda approval
IMPACT
SENTIMENT
LNTH : Nasdaq
Lantheus Announces FDA Grants PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
fda approval
IMPACT
SENTIMENT
KIDS : Nasdaq
OrthoPediatrics Corp. Receives FDA approval for 3P™ Pediatric Plating Platform™ Small-Mini System, the second of several systems in the 3P family
fda approval low float
IMPACT
SENTIMENT
MRK : NYSE
U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study
clinical trial fda approval
IMPACT
SENTIMENT
SNDX : Nasdaq
Syndax Announces FDA Approval of Revuforj® (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia
clinical trial fda approval high short
IMPACT
SENTIMENT
BAYRY : OTC BAYZF : OTC
Bayer’s Lynkuet® (elinzanetant), the First and Only Neurokinin 1 and Neurokinin 3 Receptor Antagonist, Receives FDA Approval for Moderate to Severe Hot Flashes Due to Menopause
fda approval
IMPACT
SENTIMENT
NRXS : NYSE
NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pain in Functional Dyspepsia (FD) with associated Nausea Symptoms in the Adult Patient Population
clinical trial fda approval low float
IMPACT
SENTIMENT
MRK : NYSE
FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each in Combination with Padcev® (enfortumab vedotin-ejfv), for Certain Patients with Muscle-Invasive Bladder Cancer
fda approval
IMPACT
SENTIMENT
QNRX : Nasdaq
Quoin Pharmaceuticals Announces U.S. FDA Grants Orphan Drug Designation for QRX003 in Netherton Syndrome
clinical trial fda approval low float
IMPACT
SENTIMENT
CPIX : Nasdaq RDHL : Nasdaq
CUMBERLAND PHAMACEUTICALS ANNOUNCES THE ADDITION OF AN ESTABLISHED FDA APPROVED PRODUCT TO ITS COMMERCIAL PORTFOLIO
fda approval low float
IMPACT
SENTIMENT
SINT : Nasdaq
SINTX Technologies Receives FDA Clearance for SINAPTIC® Foot & Ankle Implant System
clinical trial fda approval low float
IMPACT
SENTIMENT
GKOS : NYSE
Glaukos Announces FDA Approval of Epioxa™
fda approval
IMPACT
SENTIMENT
RHHBY : OTC
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
fda approval
IMPACT
SENTIMENT
RHHBY : OTC
FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis
fda approval
Today's News - Full List