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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
10/06/22 8:30 PM
Nasdaq : ALNY
fda approval
Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration approved a label expansion for OXLUMO ®, an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate and plasma oxalate levels in...
RHEA-AI
neutral
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™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia
IHEEZO™ 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™ 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™ reagent kit for the automation of its T-SPOT ®. 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® (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™ (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™, 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™ (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™ for injection for the temporary improvement of moderate to severe frown lines in adults. 1 DAXXIFY™ 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® (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 ® 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