FDA approves an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM syndrome (warts, hypogam...
Federal Register notice: FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Correspondin...
FDA plans a 6/13 listening session as part of its plan to revamp the use of advisory committees.
FDA offers a four-year enforcement discretion phase-out under a just-released final rule regulating laboratory-developed tests.
FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and ...
CBER director Peter Marks outlines the top priorities at the Center this year that include updating the Centers tissue guidance to reduce the risk of ...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Laboratory Values.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Performance Status.
