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08/02/22 7:15 PM
Nasdaq : CHRS
fda approval
FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis® for All Five Indications, with 12 Months of Interchangeability Exclusivity
- CIMERLI™ is Coherus’ third FDA-approved product and the first of four new product launches planned by the end of 2023 - - First CIMERLI™ product sales expected in October 2022 - - COLUMBUS AMD trial was published in the journal Ophthalmology and demonstrated the clinical equivalence of CIMERLI™
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 approvallow float
Guided Therapeutics Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva® 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™ (ruxolitinib) Cream for the Treatment of Vitiligo
Incyte today announced that the U.S. Food and Drug Administration has approved Opzelura™ 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® (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 ® 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® 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 ®, 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
06/22/22 6:50 AM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium 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 Clorazepate Dipotassium Tablets. The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million, according to IQVIA/IMS Health, a leading healthcare data and...
RHEA-AI
neutral
06/22/22 6:45 AM
NYSE : MRK
fda approval
U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children
Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration has approved an expanded indication for VAXNEUVANCE™ to include children 6 weeks through 17 years of age. The U.S. Centers for Disease Control and Prevention’ s Advisory Committee on Immunization Practices is expected to meet today to discuss and...
RHEA-AI
positive
06/17/22 8:00 AM
NYSE : ABBV
fda approval
SKYRIZI® (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults
- Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and FORTIFY 1-4- As early as week 4 in the induction
RHEA-AI
neutral
06/13/22 7:22 PM
Nasdaq : ALNY
fda approval
Alnylam Announces FDA Approval of AMVUTTRA™ (vutrisiran), an RNAi Therapeutic for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration approved AMVUTTRA™, an RNAi therapeutic administered via subcutaneous injection once every three months for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. hATTR amyloidosis...
RHEA-AI
very positive
06/06/22 10:00 AM
NYSE : GSK
fda approval
GSK announces US FDA approval of PRIORIX for the prevention of measles, mumps and rubella in individuals 12 months of age and older
GSK plc today announced that the US Food and Drug Administration has approved PRIORIX for active immunisation for the prevention of measles, mumps and rubella in individuals 12 months of age and older. PRIORIX is currently licenced in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 800...
RHEA-AI
negative
06/01/22 4:15 PM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces the FDA Approval and Imminent Launch of Fludrocortisone Acetate 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 Fludrocortisone Acetate Tablets USP, 0.1 mg. The current annual U.S. market for Fludrocortisone Acetate Tablets, 0.1 mg is approximately $24.2 million, according to IQVIA/IMS Health, a leading...
RHEA-AI
neutral
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