FDA Approvals
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After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
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Vafseo® approved by the U.S. FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients
3/28/2024
CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. announced that the U.S. Food and Drug Administration has approved Vafseo tablets for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.
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Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis
3/27/2024
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.
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Merck’s Winrevair is the second PAH drug to get the FDA’s green light in the past week, following Johnson & Johnson’s Opsynvi, which won approval on Friday.
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AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
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Actinium Announces Clinical Trial to Study Iomab-ACT Targeted Radiotherapy Conditioning with Leading FDA Approved Commercial CAR T-Cell Therapy
3/26/2024
Actinium Pharmaceuticals, Inc. announced that the University of Texas Southwestern Medical Center will lead a clinical trial studying Actinium's Iomab-ACT, a targeted radiotherapy conditioning agent prior to patients receiving an FDA approved commercial CAR T-cell therapy.
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Cerus Corporation Announces FDA Approval of Extended Shelf Life for INTERCEPT Platelet Processing Sets – Doubling Previous Shelf Life
3/26/2024
Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately.
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FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)
3/26/2024
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
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Liver-Assessment Tool Hepatoscope® Cleared for Use in U.S. and Europe Just as First Medication for MASH* Gains FDA Approval
3/26/2024
E-Scopics, the France-based medical ultrasound company and creator of a unique software-based liver assessment tool, welcomed the announcement that Madrigal Pharmaceuticals’ Rezdiffra™ (resmetirom) has been approved by the U.S. Food and Drug Administration (FDA) to treat certain forms of liver disease.
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FDA Roundup: March 26, 2024
3/26/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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FDA Approves Medexus's Supplemental Biologics License Application for IXINITY(R) to Treat Hemophilia B in Pediatric Patients
3/26/2024
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus's supplemental Biologics License Application
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Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
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The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
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AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.
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Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.
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NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression
3/25/2024
Neuronetics, Inc. announced clearance from the U.S. Food and Drug Administration (FDA) for NeuroStar Advanced Therapy for use as an adjunct for the treatment of major depressive disorder (MDD) in adolescent patients aged 15-21.
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Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension
3/25/2024
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
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GE HealthCare Announces the FDA Clearance of nCommand Lite by IONIC Health
3/25/2024
GE HealthCare (Nasdaq: GEHC) announces the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology.