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10/03/22 9:00 AM
Nasdaq : GILD
fda approval
Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product
Kite, a Gilead Company, today announced the U.S. Food and Drug Administration has approved the company's retroviral vector manufacturing facility in Oceanside, California, for commercial production. Over 10,000 patients have been treated with Kite' s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world,...
RHEA-AI
very positive
09/27/22 1:50 PM
Nasdaq : HROW
fda approval
Harrow Announces U.S. FDA Approval of IHEEZO(TM) (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia
IHEEZO(TM) Represents the First Approved Use in the U.S. Ophthalmic Market of Chloroprocaine Hydrochloride and the First Branded Ocular Anesthetic Approved for the U.S. Ophthalmic Market in Nearly 14 Years. IHEEZO(TM) was Licensed by Harrow for the U.S. and Canadian Markets From 100- Year-Old International Pharmaceutical Company Sintetica, S.A..
RHEA-AI
very positive
09/22/22 8:00 AM
NYSE : PKI
fda approval
PerkinElmer's Oxford Immunotec Receives U.S. FDA Approval for T-Cell Select to Automate Clinically Superior Tuberculosis Detection
PerkinElmer' s Oxford Immunotec today announced the U.S. Food and Drug Administration has approved the use of the T-Cell Select(TM) reagent kit for the automation of its T-SPOT (R). TB test workflow for in vitro diagnostic use by certified laboratories. "Automation closes the gap between ELISPOT and ELISA laboratory workflows, enabling more laboratories to offer...
RHEA-AI
very positive
09/21/22 7:12 PM
NYSE : LLY
fda approval
FDA Approves Lilly's Retevmo(R) (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type
Tumor-agnostic data supporting approval demonstrated an overall response rate (ORR) of 44% across multiple tumor typesFDA simultaneously grants traditional approval in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an
RHEA-AI
very positive
09/16/22 8:03 AM
Nasdaq : ABMD
fda approval
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC)
Abiomed announces two approvals from the U.S. Food and Drug Administration related to clinical research of Impella heart pumps in acute myocardial infarction cardiogenic shock patients. This press release features multimedia. "This landmark trial will be the culmination of over 20 years of research in the interventional therapy of AMI and will apply all...
RHEA-AI
positive
09/09/22 10:38 PM
NYSE : BMY
fda approval
U.S. Food and Drug Administration Approves Sotyktu(TM) (deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis
Bristol Myers Squibb today announced that the U.S. Food and Drug Administration approved Sotyktu(TM), a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1,2 Sotyktu is not recommended for use in combination...
RHEA-AI
very positive
09/08/22 7:00 AM
Nasdaq : RVNC
fda approval
Revance Announces FDA Approval of DAXXIFY(TM) (DaxibotulinumtoxinA-lanm) for Injection, the First and Only Peptide-Formulated Neuromodulator With Long-Lasting Results
Revance Therapeutics, Inc., a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States Food and Drug Administration has approved DAXXIFY(TM) for injection for the temporary improvement of moderate to severe frown lines in adults. 1 DAXXIFY(TM) is the first and only neuromodulator stabilized with...
RHEA-AI
neutral
09/02/22 1:15 PM
Nasdaq : VRTX
fda approval
Vertex Announces U.S. FDA Approval for ORKAMBI(R) (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to <24 months
Vertex Pharmaceuticals Incorporated today announced the U.S. Food and Drug Administration approved expanded use of ORKAMBI (R) to include children with cystic fibrosis ages 12 to who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. "Treating children with cystic fibrosis as early in life as...
RHEA-AI
neutral
08/29/22 8:00 PM
Nasdaq : TCON
fda approvallow float
US FDA Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab
Biocytogen Pharmaceuticals Co., Ltd. and TRACON Pharmaceuticals, Inc., today jointly announced that the U.S. Food and Drug Administration has approved the Investigational New Drug application for the initiation of a Phase 1/ 2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients,...
RHEA-AI
very positive
08/26/22 10:00 AM
Nasdaq : INCY
fda approval
Incyte Announces FDA Approval of Pemazyre(R) (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
Incyte today announced that the U.S. Food and Drug Administration has approved Pemazyre (R), a selective fibroblast growth factor receptor inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers that may impact...
RHEA-AI
very positive
08/23/22 9:00 AM
NYSE : ABT
fda approval
FDA Approves Abbott's New Spinal Cord Stimulation Device; Provides Tailored Relief to Multiple Pain Areas and Adds More Treatment Options for Evolving Pain Conditions
Abbott's new Proclaim(TM) Plus spinal cord stimulation (SCS) system offers the next generation of stimulation therapy, giving physicians the ability to treat multi-site and evolving pain The system builds on the company's proprietary therapy, BurstDR(TM) stimulation, that works by mimicking natural
RHEA-AI
neutral
08/19/22 6:45 AM
Nasdaq : AXSM
fda approval
Axsome Therapeutics Announces FDA Approval of AUVELITY(TM), the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults
AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week 1 -4 AUVELITY uses the first new oral mechanism of action approved for major depressive disorder in over 60
RHEA-AI
very positive
08/17/22 2:03 PM
Nasdaq : BLUE
fda approvalhigh short
bluebird bio Announces FDA Approval of ZYNTEGLO(R), the First Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions
Data from the Cooley' s Anemia Foundation indicate that the median age of death of patients with transfusion-dependent beta- thalassemia in the U.S. who died during the last decade was just 37 years. bluebird estimates that there are approximately 1,300-1,500 individuals with transfusion-dependent beta-thalassemia in the U.S.. "The Cooley' s Anemia...
RHEA-AI
very positive
08/17/22 7:30 AM
NYSE : OGN
fda approval
Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA(R) Biosimilar HADLIMA(TM) (adalimumab-bwwd)
Samsung Bioepis Co., Ltd. and Organon& Co. today announced the U.S. Food and Drug Administration has approved the citrate-free, high-concentration formulation of HADLIMA(TM), a biosimilar referencing HUMIRA (R). "With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an...
RHEA-AI
very positive
08/16/22 6:50 AM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Dexamethasone Tablets USP
ANI Pharmaceuticals, Inc. today announced that the Company received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Dexamethasone Tablets USP 1.5 mg, 4 mg and 6 mg. The current annual U.S. market for Dexamethasone Tablets USP 1.5 mg, 4 mg and 6 mg is approximately $59.8 million, according to IQVIA/IMS Health, a leading...
RHEA-AI
very positive
08/12/22 8:05 AM
Nasdaq : GH
fda approval
Guardant Health Receives FDA Approval for Guardant360(R) CDx as Companion Diagnostic for Daiichi Sankyo and AstraZeneca's ENHERTU(R) for Treatment of NSCLC Patients With Activating HER2 Mutations
Guardant Health, Inc., a leading precision oncology company, announced today that the U.S. Food and Drug Administration has approved its Guardant360 (R) CDx liquid biopsy test as a companion diagnostic to select patients with unresectable or metastatic HER2- mutant non-small cell lung cancer whose tumors have activating HER2 mutations for treatment with...
RHEA-AI
very positive
08/11/22 3:40 PM
OTC : RHHBY
fda approval
Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for Xofluza (R) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. However, in the U.S. 2018-2019...
RHEA-AI
very positive
08/11/22 1:00 AM
OTC : RHHBY
fda approval
Roche receives FDA approval for VENTANA MMR RxDx Panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for KEYTRUDA
Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial cancer patients, for treatment with Merck's immunotherapy KEYTRUDA. The test evaluates a panel of MMR proteins in tumours to provide important treatment information
RHEA-AI
positive
08/02/22 7:15 PM
Nasdaq : CHRS
fda approval
FDA Approves Coherus' CIMERLI(TM) (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis(R) for All Five Indications, with 12 Months of Interchangeability Exclusivity
- CIMERLI(TM) is Coherus' third FDA-approved product and the first of four new product launches planned by the end of 2023 - - First CIMERLI(TM) product sales expected in October 2022 - - COLUMBUS AMD trial was published in the journal Ophthalmology and demonstrated the clinical equivalence of CIMERLI(TM)
RHEA-AI
very positive
07/27/22 1:20 PM
NYSE : GSK
fda approval
GSK Announces US FDA Approval of Benlysta (Belimumab) for Pediatric Patients With Active Lupus Nephritis
GSK plc today announced that the US Food and Drug Administration has approved Benlysta for the treatment of children aged 5 to 17 with active lupus nephritis who are receiving standard therapy. "Active lupus nephritis is a potential serious complication in children with lupus, with most cases occurring within the first two years after their initial lupus...
RHEA-AI
neutral
07/20/22 9:00 AM
OTC : GTHP
clinical trialfda approval
Guided Therapeutics Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva(R) Advanced Cervical Scan
Guided Therapeutics, Inc., the maker of a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced that it has obtained Institutional Review Board approval to initiate its clinical trial aimed at obtaining FDA approval for the Company' s flagship product, the LuViva...
RHEA-AI
very positive
07/18/22 9:08 PM
Nasdaq : INCY
fda approval
Incyte Announces U.S. FDA Approval of Opzelura(TM) (ruxolitinib) Cream for the Treatment of Vitiligo
Incyte today announced that the U.S. Food and Drug Administration has approved Opzelura(TM) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is the first and only FDA- approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase...
RHEA-AI
positive
07/08/22 8:00 AM
Nasdaq : HZNP
fda approval
FDA Approves KRYSTEXXA(R) (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy
Horizon Therapeutics plc today announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application expanding the labeling to include KRYSTEXXA (R) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy. "Today' s approval for...
RHEA-AI
neutral
06/24/22 7:05 PM
NYSE : BMY
fda approval
U.S. FDA Approves Bristol Myers Squibb's CAR T Cell Therapy Breyanzi(R) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
Bristol Myers Squibb today announced that the U.S. Food and Drug Administration has approved Breyanzi (R), a CD19-directed chimeric antigen receptor T cell therapy, for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell...
RHEA-AI
very positive