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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
The FDA’s Antimicrobial Drugs Advisory Committee, meeting Thursday, was overwhelmingly positive in its assessment of benefits and risks of AstraZeneca’s respiratory syncytial virus (RSV) preventive treatment, nirsevimab, for children. Read More
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling. Read More