October 18, 2024
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of […]
October 18, 2024
The US Food and Drug Administration (FDA) has approved foscarbidopa and foslevodopa (Vyalev, AbbVie), a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion, […]
October 18, 2024
On This Page Date: October 29, 2024 Time: 10:00 AM – 3:30 PM ET The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the […]
October 18, 2024
Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for two vaccines: Fluad (surface antigen, inactivated, adjuvanted) and Flucelvax (surface antigen, inactivated, […]
October 18, 2024
Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
October 18, 2024
Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Eltrombopag Viatris (eltrombopag), a generic medicine for the treatment of […]
October 18, 2024
The European Medicines Agency (EMA) has upheld an earlier recommendation to deny marketing authorization for Masitinib AB Science (masitinib), an oral treatment for amyotrophic lateral sclerosis […]
October 18, 2024
The European Medicines Agency has recommended granting marketing authorization for a new hybrid formulation of buprenorphine as a substitution treatment of opioid drug dependence. Buprenorphine Neuraxpharm […]
October 18, 2024
On This Page Date: December 4 – 5, 2024 Day1: Wed, Dec 4 8:30 AM – 5:30 PM ET Day2: Thu, Dec 5 8:30 AM – […]
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