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Human Drugs

Permanent Injunction Against 3 Illinois Companies

An Illinois federal court enters a permanent injunction against three related firms to stop them from selling adulterated and misbranded dietary suppl...

Human Drugs

EMD Serono Resubmission for MS Drug

FDA accepts for review an EMD Serono NDA resubmission for cladribine tablets for treating patients with relapsing forms of multiple sclerosis.

Medical Devices

Medtronic Implantable Remodulin Delivery Device OKd

FDA approves Medtronics Implantable System for Remodulin for treating patients with pulmonary arterial hypertension.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Anigan, Milbar Laboratories and Yuki Gosei.

Medical Devices

nteger Holdings PMA Approved for RadialSeal

FDA approves an Integer Holdings PMA for its radial access introducer RadialSeal.

Human Drugs

FDA Announces FY 2019 Biosimilar User Fees

FDA publishes the biosimilar user fee schedule for FY 2019.

Human Drugs

More Repackagers Involved in Valsartan Recall

FDA increases the list of drug repackagers recalling some valsartan-containing products.

Medical Devices

FDA Cautions About Vaginal Rejuvenation Devices

FDA cautions against using energy-based medical devices for vaginal rejuvenation or cosmetic vaginal procedures.

Human Drugs

FAIR Drug Price Bill Gets Bipartisan Support

Reps. Jan Schakowsky and Francis Rooney call for more bipartisan support of the FAIR Drug Pricing Act.

Human Drugs

Raniers Rx Laboratory Recalls Sterile Compounded Drugs

Raniers Rx Laboratory recalls all sterile compounded drug products within expiry to the hospital or consumer level due to concerns that practices at t...