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FDA reviewers question the relevance of clinical trials submitted to support labeling changes for Avodart and Proscar relating the...[ Price : $8.95]
Gen-Probe files a PMA for its Aptima HPV (human papillomavirus) assay, a new molecular test that detects high-risk HPV infections ...[ Price : $8.95]
FDA extends by three months its review of an EMD Serono NDA for cladribine tablets as a therapy for relapsing forms of multiple sc...[ Price : $8.95]
FDA says it generally agrees with an HHS Inspector General recommendation that it do a better job of ensuring completeness and acc...[ Price : $8.95]
Sanofi Pasteur starts a Phase 2 clinical study involving a vaccine for primary prevention of Clostridium difficile infection.[ Price : $8.95]
FDA accepts for review a Spectrum Pharmaceuticals supplemental NDA re-submission for Fusilev (levoleucovorin) for injection for tr...[ Price : $8.95]
Advanced Bionics notifies FDA that it is voluntarily recalling its HiRes 90K cochlear implant devices due to two reported cases of...[ Price : $8.95]
FDA and industry discuss longer user fee review times to allow for a mid-review communication for feedback from reviewers on the s...