FDA Approvals
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Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 30, 2020.
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SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
9/30/2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population.
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American Regent Introduces Tralement™ (trace elements injection 4*, USP)
9/30/2020
American Regent, Inc. announces the introduction of Tralement™ (trace elements injection 4*, USP), the first and only FDA-approved multi-trace element injection.1 TralementTM is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
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Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pediatric Patients with Adrenocortical Insufficiency
9/29/2020
Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved ALKINDI® SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.
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Adial Pharmaceuticals Announces COVID-19 Point-of-Care Antibody Test Granted First Ever FDA Emergency Use Authorization for Use with Fingerstick Blood Samples
9/29/2020
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Assure COVID-19 IgG/IgM Rapid Test Device.
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Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC
9/29/2020
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Infinity is currently enrolling patients in MAR
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FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin™
9/29/2020
Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) granted expanded access for an intermediate size population allowing its proprietary therapeutic, Zofin for the treatment of COVID-19. Thi
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.
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The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
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U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
9/28/2020
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were app
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AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
9/28/2020
- Elezanumab (ABT-555) is an investigational treatment being evaluated in neurological disorders, including treatment following spinal cord injury - Orphan Drug Designation is given to a drug or biologic for the treatment, diagnosis or prevention of a rare disease or condition¹ - Fast Track Designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs²
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Masimo Announces FDA Clearance of the Rad-G™ Pulse Oximeter
9/28/2020
Masimo (NASDAQ: MASI) announced today FDA clearance of the Rad-G™ Pulse Oximeter, a rugged handheld device that provides clinically proven SET ® pulse oximetry, respiration rate from the pleth (RRp ® ), and other vital parameters for both spot-checking and continuous monitoring. With its long-lasting r
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Shionogi Announces FDA Approval of FETROJA® (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
9/28/2020
Shionogi Announces FDA Approval of FETROJA ® (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia OSAKA, Japan & FLORHAM PARK, N.J.--( BUSINESS WIRE )-- Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FETROJA ® (cefiderocol) for the treatment of patients 18 ye
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Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay
9/28/2020
Hologic, Inc. (Nasdaq: HOLX) announced today that its Panther Fusion® SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. Hologic
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U.S. Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
9/28/2020
CSL Behring, a global biotherapeutics leader, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.
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Neurophth Therapeutics' Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by U.S. FDA
9/25/2020
Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth") today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation. Leber's Hereditary O
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FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
9/25/2020
Today, the U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or lon
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FDA Approves Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
9/25/2020
GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-