News

US FDA approves syringe version of Argenx's immune disorder drug
The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...
Anti-vaccine sentiment may derail vaccines already awaiting FDA approval, experts fear
Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...
Medscape6d
FDA Approves First and Only Therapy for IgG4-RD
Inebilizumab-cdon was previously approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD) in adults who are ...
FDA says it will phase out animal testing requirement for monoclonal antibodies and drugs
The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...
FDA approves first at-home, over-the-counter test for STIs. But it's not for everyone.
The FDA announced Friday that it had approved the first at-home test for sexually transmitted infections, opening the pathway for more to come.
Biocon Biologics secures FDA approval for cancer drug Jobevne
Biocon Biologics' Jobevne, a biosimilar of Avastin, approved by the FDA, expanding oncology portfolio and access to ...
FDA Approves New DexCom Diabetes Device
The Food and Drug Administration has cleared diabetes-management firm DexCom's new continuous glucose monitoring (CGM) system ...
FDA Approves Dexcom's 15-Day Wearable Glucose Management System. Company Plans US Launch
The U.S. Food and Drug Administration approved DexCom, Inc.’s (NASDAQ:DXCM) Dexcom G7 15-Day Continuous Glucose Monitoring System for people over 18 with diabetes. With an overall Mean Absolute ...
FDA to phase out some animal testing requirements, possibly replace them with AI models
The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...
Theratechnologies Receives FDA Approval of Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA
FDA action allows for unrestricted distribution of EGRIFTA SV®, removing uncertainty with respect to all manufactured batches PAS approval follows recent FDA approval of new formulation, EGRIFTA WR™ ...
Coloradan battling rare cancer fights against National Institutes of Health medical research cuts
Katie Doble is on her computer looking to connect with anyone who might share her fight for clinical research knowing her ...
Ozempic For Weight Loss: Who Can Get the Shot, Does It Really Work, And What Do Experts Recommend?
Some celebrities who have spoken out about using the weight loss drug include Oprah Winfrey, Kelly Clarkson, and James Corden ...