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FDA and Ultragenyx reach an agreement on the design and endpoints for a Phase 3 study of the companys DTX301 ornithine transcarbam...[ Price : $8.95]
Federal Register notice: FDA announces a 6/9 public workshop entitled Model Informed Drug Development Approaches for Immunogenicit...[ Price : $8.95]
Federal Register notice: FDA posts an updated listing of Emergency Use Authorizations for molecular diagnostic and antigen tests f...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Record Retention Requirements for the Soy P...[ Price : $8.95]
FDA clears a Soundbite 510(k) for the SoundBite Crossing System Peripheral with an 0.014 Active Wire for treating peripheral arte...[ Price : $8.95]
Eli Lilly and and Incyte plan to file a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a s...[ Price : $8.95]
FDA grants Lexeo Therapeutics a fast track designation for LX1001, an adeno-associated virus mediated gene therapy for treating ap...[ Price : $8.95]
FDA says BD is recalling 30 lots of its ChloraPrep 26 mL applicator due to a defective applicator.