DexCom Gets FDA Warning Letter After Inspections of Facilities
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
US FDA expands use of ARS Pharma's allergic reaction nasal spray in 15-30 kg patients
The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' nasal spray for severe allergic ...
C&EN3d
FDA nominee Marty Makary outlines vision for improving public health
President Trump’s pick to lead the US Food and Drug Administration tells senators he will follow science and common sense ...
MPR3d
Wearable Furosemide Delivery System Approved for CKD Patients
The Food and Drug Administration (FDA) has expanded the approval of Furoscix® (furosemide injection) to include the treatment of edema in patients with ...
Pharmaceutical Technology on MSN3d
FDA approves scPharmaceuticals’ Furoscix sNDA for oedema in CKD
The US Food and Drug Administration (FDA) has approved scPharmaceuticals’ supplemental new drug application (sNDA) for ...
San Diego biotech gets FDA approval for EpiPen alternative for kids
Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...
FDA nominee sidesteps questions on abortion pill, agency layoffs and other issues
Dr. Marty Makary is largely sidestepping Senate questions about his plans to lead the Food and Drug Administration.
Fortune9d
Trump administration cuts reach FDA employees in food safety, medical devices and tobacco products
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Star Tribune14d
In Parkinson’s fight, Medtronic’s first-in-the-world adaptive therapy feature wins FDA approval
After decades of development and trials, Medtronic has secured U.S. Food and Drug Administration approval for adaptive ... Diseases at University of Florida Health. “Adaptive devices hold ...
Modern Healthcare14d
FDA approves Medtronic’s adaptive technology for Parkinson’s
Medtronic announced on Monday that the Food and Drug Administration approved its BrainSense Adaptive ... to this technology in the U.S. at select health systems in the next few weeks, with ...
News Medical15d
FDA-approved technology offers personalized treatment for Parkinson’s symptoms
Starting today, people with Parkinson's disease will have a new treatment option, thanks to U.S. Food and Drug Administration approval of ... Patients and their health care providers will be ...
Los Angeles Business Journal15d
ImmunityBio Seeks Drug Approvals
Last April, ImmunityBio achieved a major milestone when the U.S. Food and Drug Administration approved its lead drug candidate, Anktiva, to treat certain types of bladder cancers. That allowed the ...