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Biologics

Outlook Therapeutics BLA for Wet AMD Therapy

Outlook Therapeutics files a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration.

Medical Devices

Medtronic Recalls IN.Pact Balloon Catheters

Medtronic recalls a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the pote...

Human Drugs

Dont Use FarmaKeio Superior Sterile Products: FDA

FDA says patients and healthcare professionals should not use drugs purporting to be sterile produced by Richardson, TX-based FarmaKeio Superior Custo...

Human Drugs

FDA, FTC Warn 7 Companies About Covid Claims

FDA and the FTC warn seven companies they are selling unapproved and misbranded drugs containing cannabidiol as Covid-19 treatments.

FDA General

Announced/Unannounced Inspection Pilot Moves Forward

ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is beginning its long-planned pilot program to measure the impact of an...

FDA General

FDA Enterprise Data Implementation Roadmap Coming

FDA commissioner Robert Califf and chief information officer Vid Desai provide an overview of the agencys progress in data and technology modernizatio...

Human Drugs

Teva Recalls 1 Lot of IDArubicin Injection

FDA says Teva is recalling one lot of its leukemia drug IDArubicin hydrochloride injection due to the presence of particulate matter found in one vial...

Federal Register

Comments Extended on Carbadox Carcinogenic Concern

Federal Register notice: FDA extends the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to ...

Human Drugs

Monitor Thyroid in Some Babies and Children: FDA

FDA says it is recommending thyroid monitoring for children age 3 and younger who receive iodinated contrast media for imaging studies.

Human Drugs

Guilty Plea in Compounded Rx Kickback Scheme

The Justice Department says a Pennsylvania man pleaded guilty to healthcare fraud and violating the Anti-Kickback Statute in a compounded medication s...