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

FDA Accepts NDA for Investigational RA Agent

Michele B. Kaufman, PharmD, BCGP | November 1, 2023

The FDA has accepted an investigational new drug application (NDA) for MYMD-1, an oral tumor necrosis factor-α inhibitor for patients with rheumatoid arthritis.

FDA Commissioner Charts Potential & Challenges of Emerging Technologies in Patient Care

Ryan Basen | June 20, 2023

Disparities, representativeness, algorithmic bias, the disruptive emergence of large language models and continued misinformation spread are key issues poised to transform patient care in American healthcare, FDA Commissioner Robert M. Califf, MD, said during a recent event.

FDA Issues Updated Prescribing Information for Opioids & Over-the-Counter Naloxone

Michele B. Kaufman, PharmD, BCGP | June 13, 2023

New prescribing guidance has been issued by the FDA for immediate-release and extended-release/long-acting opioids for pain management. The agency also announced multiple label updates, which include changes to the Boxed Warnings.

FDA Approves Sarilumab for the Treatment of Adults with Glucocorticoid-Resistant PMR

Michele B. Kaufman, PharmD, BCGP | March 14, 2023

Sarilumab is now FDA approved to treat adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper. This new indication is based on results from the multicenter, phase 3 SAPHYR trial.

FDA Approves Abaloparatide to Treat Men with Osteoporosis & a High Risk of Fracture

Michele B. Kaufman, PharmD, BCGP | February 15, 2023

In late December, the FDA approved subcutaneous abaloparatide for the treatment of men with osteoporosis at a high risk of fracture. This approval is based on a placebo-controlled study that showed abaloparatide led to significant increases in bone mineral density of the lumbar spine, total hip and femoral neck. Abaloparatide was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

FDA Revokes Emergency Use Authorization for Evusheld

From the College | February 2, 2023

The Food & Drug Administration announced Jan. 26 that tixagevimab/cilgavimab (Evusheld) is no longer authorized for use in the U.S. The decision was based on new data suggesting that the treatment is unlikely to be active against the most common current SARS-CoV-2 variants.

First Biosimilar to Adalimumab (Humira) Enters the U.S. Market After Years of Legal Battles

Michele B. Kaufman, PharmD, BCGP | January 31, 2023

After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.