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Human Drugs

Novartis Semaglutide has Gamechanger Obesity Results

A new study finds that 35% of those taking Novartis semaglutide for treating obesity lost more than one-fifth of their total body weight, according to...

FDA General

Cancer Experts Endorse Woodcock for Commissioner

Some 94 oncology physicians, researchers, and leaders ask President Biden to nominate Janet Woodcock as FDA commissioner.

Biologics

Regenerons Evkeeza OKd for Rare High Cholesterol

FDA approves a Regeneron Pharmaceuticals BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol lowering therapi...

Human Drugs

Report Details FDA Drug Safety Efforts

CDERs sixth annual drug safety report updates the Centers typical safety activities as well as those focused on the Covid-19 pandemic.

Medical Devices

Acuitive Technologies Suture Anchor Cleared

FDA clears an Acuitive Technologies 510(k) for its Citrefix Knotless Suture Anchor System with Citregen material technology, a bioresorbable synthetic...

Federal Register

Panel Meeting Scheduled for Janssen Covid Vaccine

Federal Register notice: FDA announces a 2/26 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Janssen Biotech emergen...

Marketing

Anemic FDA Ad Enforcement Seen

Eye on FDA reports that the CDER Office of Prescription Drug Promotion continued its anemic enforcement level in 2020.

Human Drugs

Lilly EUA for Combo Monoclonal Antibody Therapy

FDA issues Eli Lilly an emergency use authorization for bamlanivimab and etesevimab administered together for treating mild to moderate Covid-19 in ad...

Human Drugs

Fresenius Kabi Oncology Pleads Guilty in Records Case

Fresenius Kabi Oncology pleads guilty and agrees to pay $50 million in fines and forfeitures for removing records showing violative activities from an...

Medical Devices

Smiths Medical Syringe Pump Recall is Class 1

FDA classifies as Class 1 a recall of Smiths Medical Medfusion Syringe Pumps (Models 3500 and 4500) due to the risk of medication delivery errors rela...