The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Source: FDA Press…
The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the…
The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7…
As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration today issued draft guidance titled “Development of Non-Opioid Analgesics for Chronic Pain” to…
The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. Source: FDA Press Releases
The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all…
The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from…
The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. Source: FDA Press Releases
FDA advanced Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability for the review of therapies intended to treat rare diseases with very small patient populations with significant…
The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. Source: FDA Press Releases