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.
An FDA advisory committee votes to recommend continued accelerated approvals separately for Mercks Keytruda and Genentechs Tecentriq in bladder cancer...
Enzyvant resubmits a BLA for RVT-802, a tissue-based regenerative therapy designed to treat pediatric congenital athymia.
A required preapproval inspection delays Sol-Gel Technologies NDA review for Epsolay (benzoyl peroxide) 5% topical cream for treating rosacea inflamma...