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FDA accepts for priority review an Astellas Pharma NDA for fezolinetant, a nonhormonal compound for treating moderate to severe va...[ Price : $8.95]
FDA warns about the potential for needle stick injuries from recently recalled Haiou Needle Retractable Safety 1 mL syringe with 2...[ Price : $8.95]
FDA is permitting Covid-19 vaccine makers to submit mouse data to expedite authorization of their omicron-protecting vaccine boost...[ Price : $8.95]
Federal Register final rule: FDA establishes a regulatory category for over-the-counter hearing aids and making related amendments...[ Price : $8.95]
FDA says it has received 168 reports of deaths in more than 69,000 medical device reports associated with PE-PUR foam degradation ...[ Price : $8.95]
FDA clears a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System for office-based pedia...[ Price : $8.95]
FDA approves the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia who require regular...[ Price : $8.95]
Attorney Brynn Stanley outlines provisions in a 2022 FDA draft cybersecurity guidance and how they differ from the 2018 draft it r...