Physicians and their patients with acromegaly will soon have access to the first drug specifically designed to block the effects of human growth hormone. The FDA recently approved pegvisomant (Somavert, Pharmacia) for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or medical therapies, or for whom those treatments are inappropriate. Pegvisomant is the first of a new class of drugs called growth hormone receptor antagonists.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.