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Medical Devices

Device Co. Kickback Scheme Costs Physician $1.75 Million

The federal government announces that Virginia physician Jeffrey R. Carlson has agreed to pay $1.75 million to resolve allegations that he accepted ki...

Medical Devices

FDA Mulls Covid-19 Serology Test Policy Change

FDA tells a Congressional briefing that it is considering tougher requirements on Covid-10 serology (antibody) tests that are on the market without no...

Human Drugs

FDA Approves Neurocrine Parkinsons Drug

FDA approves a Neurocrine Biosciences NDA for Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients w...

Medical Devices

Safety Update on Obesity Gastric Balloons

FDA sends a letter to health care providers to update risk information for gastric balloon devices used for weight loss.

Biologics

CytoDyn Files BLA Modules for HIV Therapy

CytoDyn files clinical and chemistry, manufacturing and controls portions of a BLA for leronlimab as a combination therapy in HIV patients.

FDA General

Since Our Last Issue...

Industry news you may have missed since our last issue.

Federal Register

FDA Contemplates Patent License to Sciofen

Federal Register notice: FDA announces it is contemplating a grant of an exclusive patent license to Sciogen for two patents on influenza virus recomb...

Medical Devices

Bayer Gets Reporting Variance on Essure MDRs

FDA grants a Bayer request for a variance from some medical device reporting requirements regarding its controversial Essure contraceptive.

Federal Register

Comments Extended on Minority Strategic Priorities

Federal Register notice: FDA reopens for 60 days the comment period for a 1/3 Federal Register notice seeking input from interested stakeholders on th...

Human Drugs

Janssen Pharma Files 2 sBLAs for Simponi Aria

Janssen submits two supplemental BLAs for Simponi Aria (golimumab) for treating polyarticular juvenile idiopathic arthritis and juvenile psoriatic art...