Vertex Pharmaceuticals announced Tuesday that the U.S. Food and Drug Administration has withdrawn its clinical hold on the company’s Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID). The lift on the...
Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the...
Nurix Therapeutics, Inc., a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company’s Investigational New Drug (IND)...
The U.S. Food and Drug Administration has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants suffered a serious adverse event (SAE). The study, which is assessing the investigational adeno-associated virus gene...
Merck scored big with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, a pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age. The vaccine is now designated for active...
In previous years, PTC Therapeutics has attempted to win regulatory approval for its Duchenne Muscular Dystrophy drug, Translarna (ataluren), but the U.S. Food and Drug Administration has rejected the attempts. The company believes it has data that will support...
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