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05/24/22 6:00 AM
Nasdaq : ROIV, ROIVW
fda approval
FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years
- EFFICACY: In the pivotal Phase 3 clinical trial program, VTAMA cream met all primary and secondary endpoints and demonstrated highly statistically significant improvement versus vehicle in Physician Global Assessment (PGA) score with 36% of patients versus 6% in vehicle in PSOARING 1 and 40% of
RHEA-AI
positive
05/13/22 5:54 PM
NYSE : LLY
fda approval
FDA approves Lilly's Mounjaro™ (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes
Mounjaro delivered superior A1C reductions versus all comparators in phase 3 SURPASS clinical trialsWhile not indicated for weight loss, Mounjaro led to significantly greater weight reductions versus comparators in a key secondary endpointMounjaro represents the first new class of diabetes
RHEA-AI
very positive
05/10/22 4:02 PM
Nasdaq : HOLX
fda approval
Hologic Announces FDA Approval of Aptima® CMV Quant Assay for Human Cytomegalovirus
Hologic, Inc. announced today that the U.S. Food and Drug Administration approved its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants. The test is the first to be introduced in the U.S. by Hologic for post-transplant pathogen detection and monitoring on Hologic’ s fully automated...
RHEA-AI
neutral
05/03/22 5:40 PM
Nasdaq : PHAT
fda approvallow float
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
VOQUEZNA TRIPLE and DUAL PAKs each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB), and have demonstrated superior eradication rates vs. lansoprazole-based triple therapy in the overall patient population of the pivotal Phase 3 trial 1 VOQUEZNA treatment
RHEA-AI
neutral
04/19/22 8:00 AM
Nasdaq : GILD
fda approval
Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland
Kite, a Gilead Company, today announced the U.S. Food and Drug Administration has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The Maryland site joins Kite’ s existing manufacturing facilities in Southern California and Amsterdam, Netherlands to form the largest, dedicated in-house...
RHEA-AI
very positive
04/06/22 7:00 AM
Nasdaq : BTAI
fda approvallow float
BioXcel Therapeutics Announces FDA Approval of IGALMI™ (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults
First and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder 1 IGALMI demonstrated onset of action as early as 20 minutes and high response rate with both 120 mcg and 180 mcg doses in pivotal studies
RHEA-AI
neutral
04/04/22 8:00 AM
NYSE : GE
fda approval
GE Healthcare Receives FDA Approval of First-Ever Software to Help Automate Anesthesia Delivery and Reduce Greenhouse Gas Emissions During Surgery
GE Healthcare announced today the FDA pre-market approval for its End-tidal Control software for general anesthesia delivery on its Aisys CS 2 Anesthesia Delivery System. GE Healthcare is the only manufacturer approved to offer general anesthesia delivery with end-tidal concentration control in the U.S. The company initially released the technology...
RHEA-AI
very positive
04/01/22 6:01 PM
Nasdaq : GILD
fda approval
Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)
Kite, a Gilead Company, today announced the U.S. Food and Drug Administration has approved Yescarta ® CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically...
RHEA-AI
very positive
03/29/22 1:30 PM
NYSE : PFE, GSK
fda approval
ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living With HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi B.V. as shareholders, today announced that the US Food and Drug Administration has approved Cabenuva for the treatment of HIV-1 in virologically suppressed adolescents who are 12 years of age or older and weigh at least 35 kg on a stable...
RHEA-AI
neutral
03/28/22 3:01 AM
Nasdaq : STAA
fda approval
STAAR Surgical Announces U.S. FDA Approval of EVO Visian® Implantable Collamer® Lenses
STAAR Surgical Company, a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today announced that the U.S. Food and Drug Administration has granted approval of the EVO/EVO+ Visian ® Implantable Collamer ® Lens for the correction of myopia and myopia with astigmatism. Myopia, which is also known as...
RHEA-AI
neutral
03/21/22 4:30 PM
NYSE : MRK
fda approval
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck’ s anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA- approved test,...
RHEA-AI
neutral
03/18/22 2:29 PM
Nasdaq : MRNS
fda approval
Marinus Pharmaceuticals Announces FDA Approval of ZTALMY® (ganaxolone) for CDKL5 Deficiency Disorder
Marinus Pharmaceuticals, Inc., a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the U.S. Food and Drug Administration has approved ZTALMY ® oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder, a rare form of...
RHEA-AI
positive
03/18/22 6:00 AM
Nasdaq : PONOU
fda approval
Benuvia, a Leading Drug Developer Focused on Pharmaceutical Cannabinoids, with the FDA Approved Drug SYNDROS®, Signs Definitive Agreement to Become a Publicly Traded Company through a Business Combination with Pono Capital Corp
Benuvia , a leading drug developer focused on pharmaceutical cannabinoids has entered into a definitive business combination agreement with Pono Capital Corp (Nasdaq: PONO U ) The transaction implies a combined company pro forma enterprise value of $440 millio n Benuv ia owns SYNDROS ® , the FDA
RHEA-AI
positive
03/11/22 7:51 PM
NYSE : MRK
fda approval
FDA Approves LYNPARZA® (olaparib) as Adjuvant Treatment for Patients With Germline BRCA-Mutated (gBRCAm), HER2-Negative High-Risk Early Breast Cancer Who Have Been Treated With Neoadjuvant or Adjuvant Chemotherapy
AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that LYNPARZA has been approved by the U.S. Food and Drug Administration for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA- mutated, human epidermal growth factor receptor 2- negative high-risk early breast cancer who...
RHEA-AI
positive
02/28/22 9:20 PM
Nasdaq : LEGN
fda approval
CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma
Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that the U.S. Food and Drug Administration has approved its first product, CARVYKTI™, for the treatment of adults with relapsed or refractory multiple myeloma who have received...
RHEA-AI
positive
02/28/22 7:00 AM
Nasdaq : NSPR
fda approvallow float
InspireMD Announces the Inclusion of its CGuard Carotid Stent in CREST-2 Trial Following FDA Approval of the Investigational Device Exemption Supplement Application
- CGuard ™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients - - CREST-2 Trial is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and actively engaged at more than 140 study locations - TEL AVIV, Israel,
RHEA-AI
neutral