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FDA grants Pfizer/BioNTech a priority review (user fee action due 1/2022) for a BLA for their mRNA vaccine to prevent Covid-19 in ...[ Price : $8.95]
KorvaLabs requests that its emergency use authorization for the Curative SARS-Cov-2 (Covid-19) test be revoked because it is now u...[ Price : $8.95]
FDA clears a Dexcom 510(k) for its Dexcom Partner Web application programming interface to enable invited third-party developers t...[ Price : $8.95]
FDA approves a Kadmon Pharmaceuticals NDA for Rezurock (belumosudil), a kinase inhibitor for treating certain adult and pediatric ...[ Price : $8.95]
FDA follows a Warning Letter to Jubilant Pharmovas Roorkee facility with an import alert.[ Price : $8.95]
Members of the FDA Gastroenterology and Urology Devices Panel vote to support TransMedics OCS liver system with a likely indicatio...[ Price : $8.95]
Federal Register notice: FDA sends to OMB a proposed information collection entitled Medical Conference Attendees Observations Abo...[ Price : $8.95]
Arnold & Porter attorneys give practical tips for attempting to include real-world evidence in advertising for medicinal products.