A Compounding Pharmacy Foundation-funded report says FDA should ignore a National Academies report on the safety and efficacy of compounded hormones.
The 3/17 MDUFA 5 reauthorization FDA/industry meeting covered seven topics summarized by the agency.
An FDA advisory committee votes to recommend the continuance of Genentechs accelerated approval for Tecentriq (atezolizumab) plus nab-paclitaxel for t...
FDA says Hope Biosciences Stem Cell Research Foundation can conduct a Phase 2 trial of multiple infusions of stem cells in patients with Parkinsons di...
FDA says Acceleron Pharma failed to submit the required dalantercept clinical trial information to ClinicalTrials.gov.
FDA issues Protalix BioTherapeutics a Complete Response Letter for its BLA seeking accelerated approval for pegunigalsidase alfa (PRX102) for treating...
FDA clears a Pixee Medical 510(k) for its Knee +, a surgical platform designed to assist orthopedic surgeons by providing real-time positioning of ins...
FDA releases summaries from three Biosimilar User Fee reauthorization negotiating sessions.