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Drugmakers planning to submit investigational drug, new drug or biologics license applications for pediatric drug studies should conduct clinical pharmacology studies using patients with the disease the drug is intended to treat, according to a new draft guidance released by the FDA today. Read More
Two years after issuing a refuse to file (RTF) letter to Y-mAbs regarding Omblastys (omburtamab), the FDA has agreed to hear data supporting the development of the radioisotope-linked antibody designed to deliver targeted radiation to tough-to-treat pediatric brain tumors. Read More
UCB Pharma is going big with open-label extension data showing that almost 90 percent of plaque psoriasis patients who responded to Bimzelx (bimekizumab) maintained clear skin after three years of treatment. Read More
Sarepta Therapeutics’ trial of its Duchenne muscular dystrophy drug candidate is back on track four months after the FDA stopped it when a trial participant experienced a serious adverse event (SAE) that could have been life-threatening. Read More