FDA Approval

Oct 30, 2024, 03:00 ET Invenio Imaging Receives FDA Breakthrough Device Designation for AI-based Image Analysis Module to Assist Physicians in the Evaluation of Bronchoscopic Lung Biopsies

Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced today that the U.S Food and Drug...

Oct 29, 2024, 10:35 ET American Regent introduces FDA-approved Epinephrine Injection, USP in 30 mL

American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of...

Oct 29, 2024, 08:30 ET Upcoming FDA Advisory Panel for IceCure's ProSense® Marketing Authorization Receives Large Number of Public Comments from Stakeholders

IceCure Medical Ltd. (NASDAQ: ICCM) ('IceCure', 'IceCure Medical' or the 'Company'), developer of minimally-invasive cryoablation technology that...

Oct 29, 2024, 08:30 ET Protega Pharmaceuticals Receives FDA Approval for ROXYBOND™ (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain

Protega Pharmaceuticals Inc., an innovative specialty pharmaceutical company focused on responsible pain management and the development of novel...

Oct 28, 2024, 10:15 ET Product Launch: Modius Sleep FDA-Cleared Non-Invasive Device that Treats Chronic Insomnia is Now Available for Purchase

Neurovalens, a global health-tech leader in neurotechnology, has launched its first product, Modius Sleep, to treat chronic insomnia. Neurovalens...

Oct 28, 2024, 07:00 ET Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Pediatric Achondroplasia (BEACH301)

Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target...

Oct 28, 2024, 05:00 ET Iterum Therapeutics to Host Morning Conference Call on U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

WHO: Iterum Therapeutics plc (Nasdaq: ITRM) is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of...

Oct 25, 2024, 10:15 ET VANTIS VASCULAR RECEIVES FDA CLEARANCE FOR ITS CROSSFAST™ GUIDE EXTENSION SYSTEM

Vantis Vascular, Inc., a pioneering medical technology company founded by physicians with a passion to revolutionize vascular interventions, today...

Oct 24, 2024, 16:33 ET A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced United States Food and Drug Administration (FDA) approval of the ...

Oct 24, 2024, 10:13 ET EpiVax y CUBRC obtienen contrato con la FDA para el desarrollo de péptidos de control

Oct 24, 2024, 10:00 ET Pillar Biosciences Receives CPT® Code for FDA Approved oncoReveal™ CDx Pan-Cancer Solid tumor IVD Kit

Pillar Biosciences, Inc., the leader in Decision Medicine™, today announced that they have been granted a unique CPT® Proprietary Laboratory Analyses ...

Oct 24, 2024, 09:05 ET EpiVax et CUBRC remportent un contrat de la FDA d'une valeur de 2 millions de dollars pour le développement de peptides de contrôle pour les essais d'évaluation du risque d'immunogénicité soutenant les dépôts réglementaires de médicaments génériques à base de peptides.

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, 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, 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, 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...