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11/29/21 1:10 AM
NYSE : QGEN
fda approval
QIAGEN and DiaSorin widen access to latent TB testing in the U.S. with FDA approval of QuantiFERON®-TB Gold Plus assay on LIAISON® XS
QIAGEN and DiaSorin today announced that the U.S. Food and Drug Administration has approved the LIAISON ® QuantiFERON ®- TB Gold Plus assay for use on DiaSorin’ s automated LIAISON ® XS platform.. “QuantiFERON-TB Gold Plus continues to set new standards in the global fight against TB, a disease that remains a persistent killer and...
RHEA-AI
positive
11/23/21 6:00 AM
Nasdaq : AADI
fda approvallow float
Aadi Bioscience Announces FDA Approval of its First Product FYARRO™ for Patients with Locally Advanced Unresectable or Metastatic Malignant Perivascular Epithelioid Cell Tumor (PEComa)
FYARRO is the first and only approved therapy for adults for the treatment of malignant PEComa, an ultra-rare and aggressive form of sarcoma with a strong female predominance FYARRO launch planned for Q1 2022; Investor call to be held today at 8:30 am ET LOS ANGELES, Nov. 23, 2021 (GLOBE
RHEA-AI
very positive
11/18/21 6:45 AM
NYSE : MRK
fda approval
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery
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, for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic...
RHEA-AI
neutral
11/01/21 6:30 AM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces FDA Approval of Purified Cortrophin™ Gel for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome
ANI Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved the Company’ s supplemental New Drug Application for Purified Cortrophin™ Gel for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due...
RHEA-AI
neutral
10/22/21 1:00 AM
OTC : RHHBY
fda approval
Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)
Lung cancer remains the leading cause of cancer-related deaths worldwide, with more than 2.2 million people diagnosed globally last year. 1 The VENTANA PD-L1 (SP263) Assay helps determine which non-small cell lung cancer patients may benefit from treatment with Tecentriq immunotherapy based on the
RHEA-AI
very positive
10/13/21 2:45 PM
NYSE : MRK
fda approval
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)
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, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 as determined by...
RHEA-AI
neutral
10/12/21 7:10 PM
Nasdaq : RVNC
fda approval
Revance Continues to Anticipate FDA Approval of DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines in 2021
Revance Therapeutics, Inc., a biotechnology company focused on innovative aesthetic and therapeutic offerings, responds to the public disclosure of its Form 483 pursuant to a Freedom of Information Act request that was directed to the FDA. Revance provided its response to the Form 483 in July 2021 following a pre-approval inspection and is currently...
RHEA-AI
very positive
10/11/21 12:30 PM
Nasdaq : OCUL
fda approval
Ocular Therapeutix™ Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for Intracanalicular Use for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Ocular Therapeutix, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the U.S. Food and Drug Administration has approved its Supplemental New Drug Application to broaden the DEXTENZA label to add an additional indication for the...
RHEA-AI
very positive
10/05/21 7:15 AM
NYSE : GE
fda approval
GE Healthcare Receives FDA Approval for Change in Contraindications in Prescribing Information for OptisonTM
GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration to remove hypersensitivity to‘ blood and blood products’ from the contraindications in its prescribing information for its product Optison TM. Optison is an ultrasound enhancing agent that can improve the visualization of the left ventricular border─ an...
RHEA-AI
neutral
10/01/21 5:46 PM
Nasdaq : GILD
fda approval
U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Kite, a Gilead Company, today announced the U.S. Food and Drug Administration has granted approval for Tecartus ® for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Patients can access Tecartus through 109 authorized treatment centers across the U.S.. “Adults with ALL face a significantly poorer...
RHEA-AI
very positive
09/29/21 1:00 PM
Nasdaq : MIRM
fda approvallow float
U.S. FDA Approves LIVMARLI (maralixibat) as the First and Only Approved Medication for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome One Year of Age and Older
Mirum Pharmaceuticals, Inc., a leader in rare liver disease, today announced that the U.S. Food and Drug Administration has approved LIVMARLI™ oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. LIVMARLI, a minimally absorbed ileal bile acid transporter inhibitor, is the first and only FDA-...
RHEA-AI
positive
09/23/21 9:00 AM
NYSE : BAX
fda approval
Baxter Announces U.S. FDA Approval and Launch of Ready-to-use Cardiovascular Medicine Norepinephrine in Premix Formulation
Baxter International Inc., a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration approval and commercial launch of premix Norepinephrine Bitartrate in 5% Dextrose Injection. “In a critical care situation, speed, efficiency and safety are of the utmost priority,” said Heather Knight, general...
RHEA-AI
neutral
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 approvalhigh short
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