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...
Friday morning, the U.S. Food and Drug Administration granted Emergency Use Authorization to two COVID-19 vaccines for use in children ages 6 months to 4 years old: one developed by Moderna, and the other developed by Pfizer and BioNTech. The Pfizer vaccine for this...
Rune Labs, a precision neurology company, announced its StrivePD software ecosystem for Parkinson’s disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to gather patient symptom data through quantifications made by Apple...
Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment...
Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND)...
The U.S. Food and Drug Administration (FDA) is on a mission to recuperate from the review lag seen through the early phases of COVID-19 pandemic and has provided special designations for two treatments that could improve the lives of millions with recurrent...
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