FDA approves Amjevita, a biosimilar to Humira

The U.S. Food and Drug Administration approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Amjevita is approved for the ...

FDA allows marketing of clot retrieval devices to reduce disability in stroke patients

The U.S. Food and Drug Administration, allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other ...

FDA approves Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.

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Addressing challenges of innovative cancer immunotherapy medicines

EMA workshop to discuss treatments based on genetically modified T-cells. The European Medicines Agency’s ...

FDA updates draft guidance on premarket safety notifications for dietary supplement industry

The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety ...

FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

The U.S. Food and Drug Administration issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made ...

Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of ...

FDA approves first intraocular lens with extended range of vision for cataract patients

The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, ...

FDA approves new medication for dry eye disease

The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Xiidra is the first medication in a new class of ...

FDA approves Differin Gel 0.1% for over-the-counter use to treat acne

The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 ...

FDA approves implantable device that changes the shape of the cornea to correct near vision

The U.S. Food and Drug Administration approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients ...