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Aeterna Zentaris says that its benign prostatic hyperplasia drug filed to meet its endpoint in a 39-site European Phase 3 trial.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on assay development for immunogenicity testing of therapeutic proteins.[ Price : $8.95]
Former FDA deputy commissioner Mary Pendergast warns that CDER is making stealth comparative effectiveness decisions on standard N...[ Price : $8.95]
FDA says its Pediatric Advisory Committee will review safety profiles for 13 drugs at its 12/8 meeting.[ Price : $8.95]
A panel of FDA Watchers at an industry conference gives the agency new leadership high passing marks on its attempts to improve FD...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on factors that distinguish liquid dietary supplements from beverages from ...[ Price : $8.95]
FDAs Denver District Office warns Provident Pharmaceuticals about CGMP violations and manufacture of unapproved drugs.[ Price : $8.95]
FDA says Steris has failed to transition customers to approved substitutes for its modified and unapproved SS1 Processor used to s...