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The latest FDA drug approvals include traditional approval of pralsetinib for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, a monoclonal antibody for infants and children at severe risk of respiratory syncytial virus (RSV), the first treatment for people two years of age and older with the viral skin infection molluscum contagiosum, and a treatment for an eyelid disease called Demodex blepharitis. Read More
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 14 medicines for market authorization during its July meeting including GSK’s Apretude (cabotegravir) for HIV, seven cancer treatments and a drug for relapsing multiple sclerosis. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
Amneal Pharmaceuticals’ recent complete response letter (CRL) for its investigational Parkinson’s extended-release drug IPX203 didn’t identify any issues with efficacy or manufacturing — just the safety of one of the two ingredients in the NDA. Read More
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