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FDA approves a Novartis supplemental BLA for Xolair (omalizumab) for reducing allergic reactions related to accidental exposure to...[ Price : $8.95]
Federal Register notice: FDA amends a 12/12/2023 notice requesting nominations for voting members to serve on CDERs Genetic Metabo...[ Price : $8.95]
Gilead Sciences pauses enrollment globally in its magrolimab solid tumor studies and FDA subsequently requests (XXX TENSE XXX) a p...[ Price : $8.95]
CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel announces he will retire this spring.[ Price : $8.95]
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bi...[ Price : $8.95]
FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some dia...[ Price : $8.95]
FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in a...[ Price : $8.95]
FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.