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Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t wait for every question to be answered. Read More
Two clinical trials of Mersana Therapeutics’ ovarian cancer drug UpRi (upifitamab rilsodotin) are on a partial clinical hold from the FDA because of five deaths linked to serious bleeding. Read More
Ironwood Pharmaceuticals’ Linzess (linaclotide) is the first drug to receive FDA approval to treat functional constipation in children age six to 17 years with a recommended daily dosage of 72 mcg orally. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
Specialized scientific liaisons will be key to moving rare disease drugs through the Accelerating Rare Disease Cures (ARC) Program, according to CDER Director Patrizia Cavazzoni. Read More
When preparing for meetings with regulators, it is essential that you view them as partners in the drug development process. Mark Lane, Adair Turner and Patrick Larcier of PharmaLex outline some key steps in the process.Read More
Eisai’s antiamyloid antibody Leqembi (lecanemab) got a unanimous 6-0 thumbs-up from members of the FDA’s Central and Peripheral Nervous Systems Drugs Advisory Committee, who agreed that CLARITY-AD, the drug’s confirmatory study, showed that it conferred a significant clinical benefit to patients with mild cognitive impairment or early Alzheimer’s disease. Read More