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CDER says Lexicon has failed to justify its request for an agency hearing on the Centers refusal to approve the companys NDA for s...[ Price : $8.95]
CDER releases its proposed 2023 guidance agenda showing 98 planned new and revised guidances in 18 categories.[ Price : $8.95]
FDA publishes a draft guidance with recommendations about developing drugs for treating early Lyme disease as manifested by erythe...[ Price : $8.95]
FDA says IBSA Pharma is recalling 27 lots of Tirosint-Sol oral solution due to subpotency.[ Price : $8.95]
Federal Register notice: FDA announces a 4/4-5 advisory committee meeting of the Science Advisory Board to the National Center for...[ Price : $8.95]
Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an ...[ Price : $8.95]
FDA clears a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures ...[ Price : $8.95]
Xenex Disinfection Services files a de novo petition for its LightStrike+ ultraviolet room disinfection technology.