Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
November 08, 2024 16:23 ET
|
Autolus Therapeutics plc
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia
CytoSorbents Reports Third Quarter 2024 Financial and Operational Results
November 07, 2024 16:05 ET
|
CytoSorbents
PRINCETON, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery...
CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification
November 04, 2024 07:00 ET
|
CytoSorbents
CytoSorbents submits DrugSorb-ATR Medical Device License Application to Health Canada following MDSAP Certification. Expects regulatory decision in 2025
Nearly 350 Patients Participate in the Foundation for Sarcoidosis Research Externally Led Patient-Focused Drug Development Meeting with the FDA
October 31, 2024 15:28 ET
|
Foundation for Sarcoidosis Research
Foundation for Sarcoidosis Research (FSR) hosts Externally Led Patient-Focused Drug Development (EL-PFDD) meeting for Sarcoidosis
Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy
October 29, 2024 07:48 ET
|
Praxis Bioresearch, Inc.
LOS ANGELES, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for...
FDA Grants De Novo Marketing Authorization for the Distalmotion Dexter® Surgical Robot
October 28, 2024 05:00 ET
|
Distalmotion
Lausanne, Switzerland, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Distalmotion has been granted De Novo approval by the U.S. Food and Drug Administration (FDA) to market the Dexter Surgical Robot for adult...
Quality Smart Solutions Launches GRAS Experts to Protect Against Food Safety Risks
October 25, 2024 12:24 ET
|
Quality Smart Solutions Inc.
TORONTO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- In light of McDonald’s recent recall of Quarter Pounders due to E. coli contamination, the need for stringent oversight on food ingredients has never been...
MDA Kickstart Program Receives FDA Rare Pediatric Disease Designation and Orphan Drug Designation for Congenital Myasthenic Syndrome
October 24, 2024 12:50 ET
|
Muscular Dystrophy Association
New York, Oct. 24, 2024 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) proudly announces that its groundbreaking MDA Kickstart program has received both an FDA Rare Pediatric Disease...
PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
October 23, 2024 08:00 ET
|
PharmaTher Holdings Ltd.
TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food...
NurExone’s Regenerative Medicine Therapies To Be Recognized at Fall Conferences in the USA
October 23, 2024 02:56 ET
|
NurExone Biologic Inc
NurExone’s Groundbreaking Exosome Therapies to be Showcased at Fall U.S. Conferences