FDA Approval

Jun 12, 2024, 08:00 ET Native American Business Spearheads FDA and EU GMP Standards in Cannabis Industry

Prodigy Processing Solutions ("Prodigy"), a leading innovator in GMP-compliant cannabis extraction technology, today announced its strategic...

Jun 10, 2024, 17:15 ET ALZHEIMER'S ASSOCIATION WELCOMES FDA ADVISORY COMMITTEE UNANIMOUS VOTE OF EFFICACY OF DONANEMAB FOR THE TREATMENT OF EARLY ALZHEIMER'S DISEASE

The Alzheimer's Association welcomes today's U.S. Food and Drug Administration (FDA) advisory committee's unanimous finding that donanemab (Eli...

Jun 10, 2024, 08:00 ET Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) ...

Jun 10, 2024, 07:30 ET Eilean Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lomonitinib for the Treatment of Acute Myeloid Leukemia (AML)

Eilean Therapeutics LLC, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134),...

Jun 10, 2024, 04:18 ET FDA Grants Fast Track Designation to GCBP and Novel Pharma's GC1130A

GC Biopharma (006280. KS) and Novel Pharma have announced that the U.S. FDA has granted Fast Track Designation for their jointly developed MPSIIIA...

Jun 09, 2024, 19:30 ET FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts,...

Jun 07, 2024, 08:02 ET DePuy Synthes Receives 510(k) FDA Clearance of the VELYS™ Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures

Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has received 510(k) FDA clearance...

Jun 07, 2024, 03:00 ET MLB Announces IND Approval by US FDA to Initiate Phase 1 Trial of TML-6, a New Era Multi-Target Drug for the Treatment of Alzheimer's Disease

MLB (Merry Life Biomedical Company, Ltd., Taiwan: https://www.tmlbio.com/), a biomedical company, announced that the U.S. Food and Drug...

Jun 06, 2024, 07:00 ET Nestlé Health Science agrees to acquire global rights to VOWST®, product it launched in June 2023

Seres Therapeutics, Inc. (Nasdaq: MCRB), announced today that it has agreed to a non-binding memorandum of understanding with Nestlé Health Science...

Jun 06, 2024, 06:29 ET Pierre Fabre Laboratories ha presentado la solicitud de evaluación de seguridad (IND) para PFL-002/VERT-002, un potencial tratamiento para pacientes con tumores sólidos, incluido el cáncer de pulmón no microcítico con alteraciones MET

Jun 06, 2024, 06:16 ET Pierre Fabre Laboratories kündigt IND-Antrag für PFL-002/VERT-002 an, eine potenzielle Behandlung für Patienten mit soliden Tumoren, einschließlich nicht-kleinzelligem Lungenkrebs mit MET-Alterationen

Jun 05, 2024, 14:24 ET Lumenis introduces FoLix™, the first FDA-cleared proprietary fractional laser for hair loss treatment

Lumenis Be. Ltd., a leading energy-based medical device company for aesthetic and eye care solutions, is proud to announce the launch of its...

Jun 05, 2024, 10:30 ET Enspectra Health Receives FDA Breakthrough Device Designation for AI-powered Imaging Platform Targeting Skin Cancer

Enspectra Health, a health tech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation ...

Jun 05, 2024, 08:11 ET Myrtelle Announces that the FDA has selected rAAV-Olig001-ASPA Gene Therapy Candidate for the treatment of Canavan Disease for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program

Myrtelle Inc., ("Myrtelle" or the "Company"), a clinical stage gene therapy company focused on developing transformative treatments for...

Jun 05, 2024, 08:00 ET Moon Surgical receives second FDA clearance, covering its commercial Maestro™ Robotic Surgery System

Moon Surgical, a French-American pioneer in surgical innovation, announced today the United States Food and Drug Administration (FDA) clearance for...

Jun 05, 2024, 07:00 ET FDA Approved Phase II/III Clinical Study of KPG-121 in Combination with Abiraterone as a First Line Treatment for mCRPC

Kangpu Biopharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of...

Jun 05, 2024, 07:00 ET Eko Health Raises $41 Million to Scale AI-Driven Heart and Lung Disease Detection

Eko Health, a pioneer in applying artificial intelligence for early detection of heart and lung diseases, today announced it has raised $41 million...

Jun 05, 2024, 03:15 ET Pierre Fabre annonce le dépôt d'une demande d'étude clinique pour une thérapie ciblée dans le CPNPC

Jun 05, 2024, 03:15 ET Pierre Fabre Laboratories Announce IND Filing for PFL-002/VERT-002, a Potential Treatment for Patients with Solid Tumors, Including Non-Small Cell Lung Cancer with MET Alterations

Pierre Fabre Laboratories today announced the filing of an investigational new drug ("IND") application to the U.S. Food and Drug Administration...

Jun 05, 2024, 03:15 ET Pierre Fabre Laboratories Announce IND Filing for PFL-002/VERT-002, a Potential Treatment for Patients with Solid Tumors, Including Non-Small Cell Lung Cancer with MET Alterations

Pierre Fabre Laboratories today announced the filing of an investigational new drug ("IND") application to the U.S. Food and Drug Administration...

Jun 04, 2024, 08:43 ET Single Pass and Mermaid Medical Announce Completion of the First Kronos Biopsy Closure Device Procedures in the US Post FDA Clearance

Single Pass and Mermaid Medical have confirmed that four patients were successfully treated with the Kronos Biopsy Closure device at MemorialCare...

Jun 04, 2024, 08:30 ET Ricoh launches innovative Point of Care 3D medical device manufacturing facility at Atrium Health Wake Forest Baptist

Ricoh USA, Inc. today announced its flagship Point of Care 3D medical device manufacturing facility – the RICOH 3D for Healthcare Innovation Studio....