FDA Newswatch Today's News
US FDA Accepts for Priority Review Incyte BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal
22 Jan 2021 12:00:00 UT
M2PHARMA-January 22, 2021-US FDA Accepts for Priority Review Incyte BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal - The US Food and Drug...
Canon Medical’s AI-powered, premium large bore CT receives FDA clearance
23 Jan 2021 00:00:56 UT
TUSTIN, Calif.--(BUSINESS WIRE)--Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB™ CT system, giving clinicians the opportunity to see more during radiation...
FDA clears MULTIX Impact C ceiling-mounted DR system from Siemens Healthineers
23 Jan 2021 00:00:56 UT
Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new...
FDA Software Helps Prioritize COVID Vaccinations
22 Jan 2021 23:36:00 UT
Regulatory Compliance / Coronavirus By in Chief Jan 22, 2021 An FDA data analysis tool has been offered to the national COVID-19 vaccination program to help prioritize food & beverage...
11th-Hour Deal Strips FDA Oversight of Genetically Modified Animals
22 Jan 2021 22:47:50 UT
This is the latest instance of Trump political appointees overriding the agency's scientists. The Health and Human Services Department has agreed to an industry-backed plan to effectively strip the...
FDA OKs Long-Acting Injectable Drug Regimen for HIV Treatment
22 Jan 2021 22:39:04 UT
Cabotegravir and rilpivirine, injectable formulation is the first extended-release injectable drug regimen adults with HIV that is administered once per month, according to the FDA. It is indicated...
FDA Approves Fourth-Generation Deep Brain Stimulation System for Parkinson Disease Treatment
22 Jan 2021 22:26:00 UT
The Food and Drug Administration (FDA) has approved a fourth-generation deep brain stimulation (DBS) system (Vercise Genus; Boston Scientific Corporation, Marlborough, MA). The DBS device is used to...
FDA Approves Cabenuva, First Long-Acting Injectable HIV Regimen
22 Jan 2021 20:23:17 UT
Many people living with HIV will now be able to receive their treatment through a monthly injection rather than a daily pill. The U.S. Food and Drug Administration Thursday approved ViiV...
New First-Line Kidney Cancer Combination Gets FDA Nod
22 Jan 2021 21:52:37 UT
WASHINGTON -- The FDA approved the combination of nivolumab (Opdivo) plus cabozantinib (Cabometyx) on Friday for treating advanced renal cell carcinoma (RCC) in the first-line setting. Support...
FDA clears J&J's robotic surgery system for total knee replacements
22 Jan 2021 15:12:18 UT
Johnson & Johnson’s DePuy Synthes division has received FDA clearance for its robotic-assisted orthopedic surgical platform for total knee replacements. The Velys digital joint reconstruction...

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