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Fda Approval News LIVE

Stay up to date with the latest FDA approved drugs, medical devices, and supplements. Our real-time news feed brings you timely and accurate information on all FDA approvals. Keep track of the latest developments in the healthcare industry with our comprehensive list of FDA approval news. Our web page is the go-to source for reliable and updated information on FDA approvals and the impact they have on the healthcare industry.

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02/01/23 7:00 AM
NYSE : BLCO
fda approval
Bausch + Lomb and Modulight Announce FDA Approval of ML6710i Photodynamic Laser for Use with Bausch + Lomb’s VISUDYNE® (Verteporfin for Injection)
Bausch+ Lomb Corporation, a leading global eye health company dedicated to helping people see better to live better, and Modulight Corporation, a biomedical laser company, today announced that the U.S. Food and Drug Administration has approved the ML6710i photodynamic laser for equivalent use with Bausch+ Lomb’ s VISUDYNE ®...
RHEA-AI
positive
01/31/23 6:00 AM
Nasdaq : AXNX
fda approval
Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System
Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’ s fourth-generation rechargeable sacral neuromodulation system. Axonics plans to commercially launch the...
RHEA-AI
neutral
01/30/23 7:05 AM
Nasdaq : GH
fda approval
Guardant Health receives FDA approval for Guardant360® CDx as companion diagnostic for Menarini Group’s ORSERDU™ for treatment of patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer
Guardant Health, Inc., a leading precision oncology company, announced today that the U.S. Food and Drug Administration has approved its Guardant360 ® CDx liquid biopsy test as a companion diagnostic to identify advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™, a nonsteroidal selective...
RHEA-AI
very positive
01/27/23 2:07 PM
NYSE : LLY
fda approval
U.S. FDA Approves Jaypirca™ (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor
Loxo@ Lilly, the oncology unit of Eli Lilly and Company, today announced that the U.S. Food and Drug Administration approved Jaypirca™ for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor. Jaypirca was approved under the FDA's...
RHEA-AI
positive
01/27/23 6:45 AM
NYSE : MRK
fda approval
FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)
Merck, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck’ s anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB, II, or IIIA non-small cell lung cancer.
RHEA-AI
neutral
01/26/23 8:02 AM
NYSE : MRK
fda approval
Merck Animal Health Receives U.S. FDA Approval of Expanded Indication for BRAVECTO (fluralaner) Chews for Dogs
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck& Co., Inc., Rahway, N.J., USA, today announced the U.S. Food and Drug Administration’ s approval of an expanded indication for BRAVECTO ® Chews for Dogs. “The approval of this additional BRAVECTO use builds on the strong foundation and body of scientific evidence...
RHEA-AI
neutral
01/25/23 8:17 AM
OTC : AKBLF
fda approval
U.S. FDA Approves ALK's ODACTRA® (House Dust Mite Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Adolescents
ALK, a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration approved ODACTRA ® Tablet for Sublingual Use for the treatment of house dust mite- induced allergic rhinitis in persons ages 12 through 17. ODACTRA was first launched for adults, ages...
RHEA-AI
negative
12/22/22 9:55 PM
OTC : RHHBY
fda approval
FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved Lunsumio ® for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Lunsumio will be available in the United States in the coming weeks. “This approval is a significant milestone...
RHEA-AI
positive
12/22/22 10:27 AM
Nasdaq : GILD
fda approval
Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV
Gilead Sciences, Inc. today announced that Sunlenca ®, in combination with other antiretroviral, has been granted approval by the U.S. Food and Drug Administration for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. Sunlenca has a multi-stage mechanism of action distinguishable from...
RHEA-AI
positive
12/21/22 3:08 PM
OTC : RHHBY
fda approvalcovid-19
FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved Actemra ® intravenous for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane...
RHEA-AI
very positive
12/21/22 9:00 AM
Nasdaq : ABMD
clinical trialfda approval
FDA Approves Impella ECP Pivotal Heart Pump and First Patients Enrolled in Pivotal Clinical Trial
Abiomed announces the United States Food and Drug Administration has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial. Amir Kaki, MD, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, led the procedures. This single-arm,...
RHEA-AI
neutral
12/19/22 4:56 PM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces the FDA Approval and Launch of Levocarnitine Tablets USP
ANI Pharmaceuticals, Inc. today announced that it received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Levocarnitine Tablets USP, 330 mg. The current annual U.S. market for Levocarnitine Tablets is approximately $10.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
RHEA-AI
neutral
12/13/22 5:00 AM
NYSE, Nasdaq : QGEN, MRTX
fda approval
QIAGEN receives FDA approval for companion diagnostic to Mirati Therapeutics’ KRAZATI in non-small cell lung cancer
QIAGEN has announced the U.S. Food and Drug Administration approval of its therascreen ® KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutic’ s drug KRAZATI ® for non-small cell lung cancer. QIAGEN and Mirati Therapeutics, Inc., a targeted oncology company, announced their cooperation in May 2021.
RHEA-AI
very positive
12/12/22 8:50 PM
NYSE : A
fda approval
Agilent Resolution ctDx FIRST Receives FDA Approval as a Liquid Biopsy Companion Diagnostic Test for Advanced Non-small Cell Lung Cancer
Agilent Technologies Inc. announced today that the U.S. Food and Drug Administration has approved Agilent Resolution ctDx FIRST as a companion diagnostic to identify advanced non-small cell lung cancer patients with KRAS G12C mutations who may benefit from treatment with KRAZATI TM. “Expanding access to accurate and fast genomic profiling is an...
RHEA-AI
positive
12/09/22 10:48 AM
NYSE : ELAN
fda approval
Elanco Announces FDA Approval of Bexacat™ (bexagliflozin tablets) – the First-of-its-Kind Oral Feline Diabetes Treatment Option
Today Elanco Animal Health announced the U.S. Food and Drug Administration approved Bexacat™, the first orally administered prescription medication to improve glycemic control in cats with diabetes mellitus, expanding Elanco’ s innovative feline portfolio while addressing an unmet need for this chronic condition in adult cats. An estimated 600,000 cats...
RHEA-AI
neutral
12/06/22 7:00 AM
Nasdaq : BCDA
fda approvallow float
BioCardia Announces FDA Approval of IND Application for Allogeneic NK1R+ Human Mesenchymal Stem Cells for Ischemic Heart Failure
BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Food and Drug Administration approval of its Investigational New Drug application to initiate a first-in-human Phase I/II clinical trial of its Neurokinin-1 receptor positive allogeneic human...
RHEA-AI
neutral
12/01/22 5:03 PM
Nasdaq : RIGL
fda approval
Rigel Announces U.S. FDA Approval of REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
REZLIDHIA is a potentially market-leading, oral, mutant isocitrate dehydrogenase-1 (mIDH1) inhibitorPhase 2 registrational data supporting the approval showed a 35% CR+CRh rate in mIDH1 R/R AML patients with a median duration of response of 25.9 monthsConference call and webcast to be held today
RHEA-AI
very positive
12/01/22 8:00 AM
Nasdaq : SCYX
fda approval
SCYNEXIS Announces FDA Approval of Second Indication for BREXAFEMME® (ibrexafungerp tablets) for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis
BREXAFEMME, an oral, non-azole medication, is the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the reduction in the incidence of recurrent VVC. Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of
RHEA-AI
positive
11/28/22 6:50 AM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP
ANI Pharmaceuticals, Inc. today announced that the Company received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Fluoxetine Oral Solution, USP 20 mg/5 mL. The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA/IMS Health, a leading healthcare data and...
RHEA-AI
neutral
11/16/22 6:50 AM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces the FDA Approval and Launch of Trimethoprim Tablets USP
ANI Pharmaceuticals, Inc. today announced that it received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Trimethoprim Tablets USP, 100 mg. The current annual U.S. market for Trimethoprim Tablets is approximately $16.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
RHEA-AI
very positive
11/11/22 8:00 AM
Nasdaq : IMMX
clinical trialfda approvallow float
Immix Biopharma Receives Institutional Review Board Approval to Enroll Pediatric Patients in Upcoming IMX-110 Clinical Trial, Key Requirement for U.S. Food and Drug Administration Approval of Rare Pediatric Disease Priority Review Voucher
Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”) While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report on drug
RHEA-AI
very positive
11/10/22 1:12 PM
Nasdaq : SGEN
fda approval
Seagen Announces U.S. FDA Approval of New Indication for ADCETRIS® (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma
Seagen Inc. today announced that the U.S. Food and Drug Administration has approved ADCETRIS ® for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. The approval is based on data from a phase 3 study...
RHEA-AI
very positive
11/02/22 7:01 AM
Nasdaq : GILD
fda approval
U.S. Food and Drug Administration Approves Vemlidy® (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the supplemental new drug application for Vemlidy ® 25 mg tablets as a once-daily treatment for chronic hepatitis B virus infection in pediatric patients 12 years of age and older with compensated liver disease. It is recommended as a preferred or first-line...
RHEA-AI
neutral
10/31/22 8:02 AM
Nasdaq : ABMD
fda approval
Impella RP Flex with SmartAssist Receives FDA Approval to Treat Right Heart Failure
Abiomed announces that Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration pre-market approval, the FDA’ s highest level of approval, as safe and effective to treat acute right heart failure for up to 14 days. Impella RP Flex is implanted via the internal jugular vein, which enables patient mobility, and has dual-sensor technology...
RHEA-AI
neutral