These frequently asked questions have been developed for the CDER Small Business and Industry Assistance Web site to help small pharmaceutical businesses understand the regulatory process […]
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with […]
Compounders sometimes produce drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in […]
Updated August 21, 2023 FDA is evaluating bulk drug substances that were nominated for inclusion on the 503B bulks list, proceeding case by case, under the […]
TOPLINE: In patients with localized pancreatic ductal adenocarcinoma (PDAC), failure to undergo resection following neoadjuvant chemotherapy is common and associated with worse survival. Researchers identified few […]
New expert guidance to help clinicians manage the treatment of patients with epilepsy during pregnancy has been released. Issued by the American Academy of Neurology, the […]
TOPLINE: In a retrospective study of children with acrochordons (skin tags), the prevalence of metabolic syndrome, including obesity, hypertension, dyslipidemia, and elevated liver enzymes, was increased. […]
In an experiment that pitted the wits of pediatric dermatologists against ChatGPT versions 3.5 and 4.0 to answer board examination–type questions, pediatric dermatologists outperformed both iterations […]
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