FDA Identifies ResMed’s Recall Of Certain Ventilator Device Masks With Magnets As Most Serious
ResMed (NYSE: RMD) recalls certain respiratory masks with magnets due to potential interference with medical devices. FDA Class I recall.
FDA Finds No Evidence Weight-Loss Drugs Cause Suicidal Thoughts
The FDA released an update on Thursday stating that its preliminary review did not find definitive evidence that the drugs cause suicidal thoughts or actions. However, the FDA investigation will continue because a link could not be ruled out to due the small number of suicidal thoughts or actions observed in both people using the drugs and in the comparative control groups.
FDA Allows Importing Unapproved But Essential Syphilis Treatment Amid Shortage Of Pfizer’s Antibiotic
FDA collaborates with Laboratoires Delbert to address syphilis treatment shortage. Learn about the temporary import of Extencilline, an alternative to Bicillin. Shortage expected until June.
Why Is Microbiome-Based Seres Therapeutics Stock Trading Higher Today?
Seres Therapeutics Inc (NASDAQ: MCRB) received FDA Fast Track Designation for SER-155, an investigational oral, cultivated microbiome therapeutic designed to prevent GI-associated bacterial infections and to reduce the incidence of severe acute graft-versus-host disease in immunocompromised patients un
Inspira Announces Plans To Launch And Target Single-Use Disposable Blood Oxygenation Kit For A New Disposable Perfusion Market Opportunity; The Kit, Anticipated To Be Submitted For U.S. FDA Authorization In 2025
The kit is being designed for the INSPIRA™ ART device series and is intended to be compatible with various life support machines sold in the market RA'ANANA, Israel, Jan. 9, 2024 /PRNewswire/ -- Inspira
Simulations Plus Embarks On Collaboration With Northeastern University And The TIM Company Through New FDA Grant
Partnership aims to integrate experimental data and PBPK modeling to identify key formulation factors to accelerate modified-release product developmentSimulations Plus, Inc. (NASDAQ:SLP), a leading provider of modeling
SELLAS Life Sciences Receives FDA Fast Track Designation For SLS009 For Treatment Of Relapsed/Refractory Acute Myeloid Leukemia And Provides Updated Data For Phase 2a Study Of SLS009 In Relapsed/Refractory Acute Myeloid Leukemia Patients
- Phase 2a Enrollment Completed in 45 mg Safety Cohort: Median Overall Survival (OS) Not Reached; 89% of Patients Alive with Significant Antileukemic Effect Observed in 87.5% of Evaluable Patients -- First Enrolled
FDA Approves Medtronic Percept RC Neurostimulator With Exclusive BrainSense Technology
Rechargeable neurostimulator joins the Medtronic Percept™ family – the first and only deep brain stimulation system with sensing, directionality, and advanced programming.DUBLIN, Jan. 8, 2024
Owlet Transforms Infant Care With The Launch Of Two FDA-Cleared Devices, Dream Sock And BabySat
These new, innovative devices empower caregivers to monitor what matters most with reliable, medical-grade technology.Owlet, Inc. ("Owlet" or the "Company") (NYSE:OWLT), the pioneer of smart infant monitoring, today
Cancer Cell Therapy Focused Marker Therapeutics Announces Pipeline Prioritization
Marker Therapeutics Inc (NASDAQ: MRKR) announced it is restructuring its clinical programs and strategic prioritization of its multi-tumor associated antigen (multiTAA)-specific T cell product pipeline.