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01/21/22 6:24 PM
Nasdaq : GILD
fda approvalcovid-19
FDA Approves Veklury® (Remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has granted expedited approval of a supplemental new drug application for Veklury ® for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. This approval expands the role...
RHEA-AI
neutral
01/14/22 3:30 PM
NYSE : PFE
fda approval
U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis
Pfizer Inc. announced today that the United States Food and Drug Administration approved CIBINQO ®, an oral, once-daily, Janus kinase 1 inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those...
RHEA-AI
neutral
01/13/22 1:36 PM
NYSE : ZTS
fda approval
Zoetis Announces FDA Approval of Solensia™ (frunevetmab injection) to Control Osteoarthritis Pain in Cats
Zoetis Inc. today announced that the U.S. Food and Drug Administration has approved Solensia™ to control the pain of osteoarthritis in cats, helping improve their mobility, comfort and overall well-being. 1 As a once-monthly injection administered in the veterinary clinic, Solensia keeps OA pain from disrupting the unique bond cats share with their humans.
RHEA-AI
neutral
12/30/21 4:30 PM
Nasdaq : XERS
fda approval
Xeris Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome
Xeris Biopharma Holdings, Inc., a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced the U.S. Food and Drug Administration approval of Recorlev ® for the treatment of endogenous hypercortisolemia in adult patients with Cushing’ s...
RHEA-AI
very positive
12/22/21 4:23 PM
Nasdaq : ALNY
fda approval
Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduce LDL-C
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and Drug Administration’ s approval of Leqvio ®, the fourth small interfering RNA therapy approved in the U.S., and the first and only to lower low-density lipoprotein cholesterol. Alnylam scientists discovered inclisiran and published...
RHEA-AI
very positive
12/21/21 6:50 AM
Nasdaq : ANIP
fda approvallow float
ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Rifabutin Capsules USP
ANI Pharmaceuticals, Inc. today announced that the Company received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Rifabutin Capsules USP, 150 mg. The current annual U.S. market for Rifabutin Capsules USP, 150 mg is approximately $16.6 million, according to IQVIA/IMS Health, a leading healthcare data and analytics...
RHEA-AI
very positive
12/20/21 6:14 PM
NYSE : GSK, PFE
fda approval
ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration approved Apretude, the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.
RHEA-AI
neutral
12/17/21 11:01 AM
NYSE : CTLT
fda approval
Edenbridge Pharmaceuticals Announces U.S. FDA Approval of DARTISLA ODT (Glycopyrrolate) Orally Disintegrating Tablets
Edenbridge Pharmaceuticals, LLC today announced that it has received approval from the U.S. Food and Drug Administration on its 505 New Drug Application for DARTISLA ODT orally disintegrating tablets. “We are thrilled to receive approval for DARTISLA ODT, which will provide physicians and patients with a novel treatment option,” remarked Daniel G. Worley Jr.,...
RHEA-AI
very positive
12/14/21 4:08 PM
NYSE : PFE
fda approval
U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved the supplemental New Drug Application for XELJANZ ®/ XELJANZ ® XR for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. “We are proud to offer XELJANZ, a treatment...
RHEA-AI
very positive
12/03/21 6:15 PM
NYSE : MRK
fda approval
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Pediatric (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection
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 adult and pediatric patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for KEYTRUDA as adjuvant...
RHEA-AI
neutral
12/01/21 2:21 PM
Nasdaq : HALO
fda approval
Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in combination with Kyprolis ® (carfilzomib) and
RHEA-AI
very positive
12/01/21 1:28 PM
Nasdaq : AMGN
fda approval
FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone For Patients With Multiple Myeloma At First Or Subsequent Relapse
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS ® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO ® (daratumumab and
RHEA-AI
neutral
12/01/21 7:30 AM
Nasdaq : VBIV
fda approval
VBI Vaccines Announces FDA Approval of PreHevbrio™ for the Prevention of Hepatitis B in Adults
VBI Vaccines Inc., a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration has approved PreHevbrio™ for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. PreHevbrio contains the S,...
RHEA-AI
neutral
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