FDA Approval

Oct 24, 2024, 09:05 ET EpiVax und CUBRC erhalten FDA-Auftrag im Wert von 2 Millionen Dollar für die Entwicklung von Kontrollpeptiden für Immunogenitäts-Risikobewertungstests zur Unterstützung von Zulassungsanträgen für generische Peptidmedikamente

Oct 24, 2024, 09:05 ET EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays Supporting Regulatory Filings of Generic Peptide Drugs

EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announce today that they have been awarded a two-year, $2 million contract (#75F40124C00094) from...

Oct 24, 2024, 07:00 ET Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral DHX9 Inhibitor

Accent Therapeutics, a biopharmaceutical company pioneering novel small molecule targeted cancer therapeutics, today announced that the U.S. Food and ...

Oct 23, 2024, 12:35 ET FDA Awards Orphan Drug Designation for Brain Cancer Drug Development by Rosalind Franklin University Helix 51 Company

U.P. Oncolytics, a company in Rosalind Franklin University's Helix 51 biomedical incubator, has been awarded Orphan Drug designation by the FDA's...

Oct 23, 2024, 08:31 ET ResVita Bio Announces Successful FDA INTERACT Meeting for RVB-003 Therapy for Netherton Syndrome

ResVita Bio, a synthetic biology company developing innovative therapies for skin diseases, today announced a productive FDA INTERACT meeting held on ...

Oct 22, 2024, 10:00 ET Peytant Solutions, Inc. Granted FDA De Novo for AMStent® Tracheobronchial Covered Stent System

Peytant Solutions, Inc. (Peytant) today announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization (clearance to...

Oct 22, 2024, 09:00 ET Remedy Pharmaceuticals Announces FDA Orphan Drug Designation Granted for the Treatment of Large Territory Acute Ischemic Stroke with CIRARA

Remedy Pharmaceuticals, a pioneer in stroke drug development, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan...

Oct 21, 2024, 13:00 ET Adcentrx Therapeutics Announces FDA Clearance of Investigational New Drug Application for ADRX-0405, a Potential First-in-Class ADC Targeting STEAP1 for the Treatment of Advanced Solid Tumors

Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other...

Oct 18, 2024, 19:44 ET BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)

Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of BOTOX® Cosmetic for temporary improvement in the...

Oct 18, 2024, 16:01 ET Boston Scientific Launches Next Generation of Cardiac Mapping for the FARAPULSE™ Pulsed Field Ablation System

Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the navigation-enabled ...

Oct 18, 2024, 14:13 ET Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has...

Oct 17, 2024, 11:01 ET Imágenes de fluorescencia de MolecuLight: Un cambio en la detección de biopelículas en la cama del paciente

Oct 17, 2024, 10:58 ET MolecuLight's Fluoreszenz Bildgebung: Ein Wendepunkt für die Biofilm-Detektion am Krankenbett

Oct 17, 2024, 10:20 ET Imagerie de fluorescence de MolecuLight : Un changement de donne pour la détection des biofilms au chevet du patient

Oct 17, 2024, 08:00 ET U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) as the first ...

Oct 17, 2024, 06:13 ET MolecuLight's Fluorescence Imaging: A Game-Changer for Bedside Biofilm Detection

MolecuLight Inc., the global leader in fluorescence imaging technology for real-time detection of harmful bacteria in wound care, provides the most...

Oct 17, 2024, 06:13 ET MolecuLight's Fluorescence Imaging: A Game-Changer for Bedside Biofilm Detection

PITTSBURGH, Oct. 17, 2024 /PRNewswire/ - MolecuLight Corp., the global leader in fluorescence imaging technology for real-time detection of harmful...

Oct 16, 2024, 15:17 ET Restore Robotics Seeks FDA 510(k) Clearance for Remanufacturing Da Vinci Xi® 8mm Monopolar Curved Scissors

Restore Robotics, a leader in surgical robotics innovation, today announced that its subsidiary, Iconocare Health, submitted an additional 510(k)...

Oct 16, 2024, 08:00 ET Orasis Pharmaceuticals Announces Licensing Agreement with Optus Pharmaceuticals for Commercialization of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% in Korea

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the signing of an...

Oct 16, 2024, 03:00 ET XYRA Announces FDA Label Guidance for Managing Atrial Fibrillation with Budiodarone and Wearable Monitoring Devices

XYRA LLC, a private biopharmaceutical company, is committed to developing innovative therapies for cardiac rhythm disorders with high unmet needs....

Oct 15, 2024, 11:47 ET Amai Proteins wins multiple regulatory approvals for its calorie-free sweet protein: sweelin®

Advancing Sugar Reduction & Reformulation Summit - Amai Proteins, a designer of novel proteins that answer the needs of consumers and industry, has...