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09/22/21 12:38 PM
Nasdaq : INCY
fda approval
Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)
Incyte today announced that the U.S. Food and Drug Administration has approved Jakafi ® for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. “GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant,...
RHEA-AI
positive
09/21/21 4:13 PM
Nasdaq : INCY
fda approval
Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)
Incyte today announced that the U.S. Food and Drug Administration has approved Opzelura™ cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies...
RHEA-AI
neutral
09/17/21 4:23 PM
Nasdaq : EXEL
fda approval
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Exelixis, Inc. today announced that the U.S. Food and Drug Administration approved CABOMETYX ® for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth factor receptor- targeted therapy and who are...
RHEA-AI
very positive
08/31/21 4:05 PM
NYSE : MRK
fda approval
FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Certain Patients With Urothelial Carcinoma (Bladder Cancer)
Merck, known as MSD outside the United States and Canada, today announced a label update for KEYTRUDA, Merck’ s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma in the U.S. The U.S. Food and Drug Administration has converted this indication from an accelerated to a full approval. This label update follows the FDA’ s Oncologic Drugs...
RHEA-AI
very positive
08/26/21 7:00 AM
Nasdaq : IRWD
fda approval
Ironwood Pharmaceuticals Announces FDA Approval of Revised LINZESS® (linaclotide) Label
Ironwood Pharmaceuticals, Inc., a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration approved a revised label for LINZESS ® based on clinical safety data that has been generated thus far in pediatric studies. The updated label modifies the boxed warning for risk of serious dehydration and contraindication against...
RHEA-AI
neutral
08/24/21 7:00 AM
OTC : GWHP
fda approvalcovid-19
FDA Approves First COVID-19 Vaccine Which Can Be Distributed by Global WholeHealth Partners Corp (OTC: GWHP) as US Anticipates Considerable Uptick in Vaccination Rates, as Stated in 8K Filing 06/15/21
via NewMediaWire – Global WholeHealth Partners Corp. (OTC: GWHP) is readying for sales due to the transition from Emergency Use Status to Full FDA Approval of Vaccine developed by Pfizer-BioNTech, as stated in 8K filing 06/15/21. The agreement
RHEA-AI
very positive
08/24/21 1:00 AM
Nasdaq : CARA
fda approval
Vifor Pharma and Cara Therapeutics announce U.S. FDA approval of KORSUVA™ injection for the treatment of moderate-to-severe pruritus in hemodialysis patients
Regulatory News:This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005635/en/Vifor Pharma and Cara Therapeutics (Nasdaq:CARA) today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for
RHEA-AI
very positive
08/23/21 3:41 PM
Nasdaq : CARA
fda approval
Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of KORSUVA™ (difelikefalin) injection for the treatment of moderate-to-severe pruritus in hemodialysis patients
First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis Promotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022 Company to host conference call today
RHEA-AI
very positive
08/13/21 7:00 PM
NYSE : MRK
fda approval
FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who
RHEA-AI
neutral
08/11/21 6:30 PM
NYSE : MRK
fda approval
FDA Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC)
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor
RHEA-AI
neutral
07/27/21 6:30 AM
NYSE : MRK
fda approval
FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with
RHEA-AI
neutral
07/20/21 5:21 PM
Nasdaq : ALBO
fda approval
MULTIMEDIA UPDATE - Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
– Only once-daily drug indicated for the treatment of pruritus in PFIC – – Commercial launch of Bylvay immediate; available for prescription in the coming days – – Rare Pediatric Disease Priority Review Voucher issued to Albireo by the FDA – – Company to host investor conference call on July 21 at
RHEA-AI
neutral
07/20/21 4:00 PM
Nasdaq : ALBO
fda approval
Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
– Only once-daily drug indicated for the treatment of pruritus in PFIC – – Commercial launch of Bylvay immediate; available for prescription in the coming days – – Rare Pediatric Disease Priority Review Voucher issued to Albireo by the FDA – – Company to host investor conference call on July 21 at
RHEA-AI
neutral
07/19/21 8:00 AM
Nasdaq : LGND
fda approval
Ligand’s Partner Merck Receives FDA Approval for VAXNEUVANCE™ for the Prevention of Invasive Pneumococcal Disease in Adults Caused by 15 Serotypes
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Merck has received approval from the U.S. Food and Drug Administration (FDA) for VAXNEUVANCE TM, also known as V114, for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B,
RHEA-AI
very positive
07/16/21 5:15 PM
NYSE : MRK
fda approval
Merck Announces U.S. FDA Approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes
(NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by
RHEA-AI
positive
07/12/21 8:12 AM
Nasdaq : HALO
fda approval
Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and
RHEA-AI
very positive
07/01/21 8:35 AM
Nasdaq : PBYI
fda approval
FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX® that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL
RHEA-AI
neutral
06/30/21 8:04 PM
Nasdaq : JAZZ
fda approval
Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze ™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of
RHEA-AI
very positive