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Articles tagged with "U.S. Food and Drug Administration (FDA)"

Dermatology Patients on Corticosteroids May Not Receive Osteoporosis Screenings; Plus FDA Approves ZTLido

Michele B. Kaufman, PharmD, BCGP  |  March 28, 2018

A recent study found that dermatology patients taking long-term steroids are not always evaluated for steroid-induced osteoporosis…

Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead

Michele B. Kaufman, PharmD, BCGP  |  February 20, 2018

The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…

FDA Receives Reports of Loperamide Abuse

Michele B. Kaufman, PharmD, BCGP  |  February 14, 2018

The FDA is seeking to limit the number of loperamide doses per package due to reports of heart-related problems and death from the misuse and abuse of the treatment…

Upadacitinib Receives Breakthrough Designation, Abatacept Use Expands in Australia & More

Michele B. Kaufman, PharmD, BCGP  |  January 31, 2018

The FDA has designated upadacitinib a breakthrough therapy to treat adults with moderate to severe atopic dermatitis…

FDA Removes Boxed Warning for Combination Asthma Treatment

Michele B. Kaufman, PharmD, BCGP  |  January 10, 2018

Post-market clinical safety trials have indicated that medications containing both long-acting beta agonists (LABAs) and inhaled corticosteroids (ICSs) do not result in more serious asthma-related outcomes than treatment with ICSs alone…

New Drug Approvals Hit 21-Year High in 2017

Ben Hirschler  |  January 2, 2018

LONDON (Reuters)—U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union. The European Union (EU) recommended 92 new drugs, including generics, up from 81; and China laid out plans to speed up approvals in what…

Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA

Michele B. Kaufman, PharmD, BCGP  |  January 2, 2018

In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for RA patients…

Limbrel Linked to Possible Fatal Adverse Events

Michele B. Kaufman, PharmD, BCGP  |  December 12, 2017

The FDA is investigating serious and potentially fatal side effects associated with Limbrel, which is designed to manage metabolic processes in patients with osteoarthritis…

U.S. Approves Digital Pill that Tracks When Patients Take It

Reuters Staff  |  November 14, 2017

(Reuters)—U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.1 The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking…

Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis

Michele B. Kaufman, PharmD, BCGP  |  November 3, 2017

In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…

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