FDA Approvals
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Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
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Fierce competition. Thin pipelines. Patent cliffs. The stakes are sky-high for pharmaceutical companies and investors alike.
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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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Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.
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U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
4/18/2024
Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO.
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FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
4/18/2024
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.
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Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer
4/18/2024
Lumicell, Inc. today announced the U.S. Food & Drug Administration (FDA) approved the company’s New Drug Application (NDA) for its LUMISIGHT™ (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™.
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Scopio Labs Receives Groundbreaking FDA Clearance for First-Ever Digital Bone Marrow Aspirate Application
4/17/2024
Scopio Labs today announced that it has been granted De Novo clearance by the U.S. Food and Drug Administration (FDA) for its Full-Field Bone Marrow Aspirate™ (FF-BMA) Application.
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Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy
4/16/2024
Lexeo Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA) cardiomyopathy.
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Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.
4/15/2024
Fresenius, via its operating company Fresenius Kabi, announced the immediate U.S. availability of Tyenne®, a biosimilar of Actemra®.
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FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection
4/15/2024
Soligenix, Inc. announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection."
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The FDA on Thursday approved the label expansion of AstraZeneca’s Fasenra as an add-on maintenance treatment for severe eosinophilic asthma in patients six to 11 years of age.
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FDA Roundup: April 12, 2024
4/12/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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XCOPRI® (cenobamate tablets) CV Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube
4/11/2024
SK Life Science, Inc. today announced the U.S. Food and Drug Administration (FDA) approved two new administration options of XCOPRI® (cenobamate tablets) CV, an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.
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Candel Therapeutics Receives FDA Orphan Drug Designation for CAN-2409 for the Treatment of Pancreatic Cancer
4/11/2024
Candel Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, for the treatment of pancreatic cancer.
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FASENRA approved for treatment of children aged 6 to 11 with severe asthma
4/11/2024
AstraZeneca’s FASENRA® is now approved by the US Food and Drug Administration for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.
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ASTCT Supports the FDA's Approval of Earlier Use of CAR T-Cell Therapy for Multiple Myeloma
4/10/2024
The American Society for Transplantation and Cellular Therapy® (ASTCT®) supports the decision by the U.S. Food and Drug Administration's (FDA) to grant multiple myeloma patients earlier access to CAR T-cell therapy Abecma as a second-line treatment and the CAR T therapy Carvykti as a third-line treatment.
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AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
4/10/2024
AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment of septic shock.
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16 Bit Announces FDA De Novo Marketing Authorization of Rho, an AI-enabled Opportunistic Pre-Screen for Low Bone Mineral Density on Standard X-Rays
4/10/2024
16 Bit Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo marketing authorization for Rho™, an AI-enabled software device aimed at improving a known care gap in osteoporosis screening.
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Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma
4/9/2024
Lisata Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Orphan Drug Designation (“ODD”) to LSTA1.