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Pharmaceutical Research and Manufacturers of America says FDA should halt efforts on finalizing its draft guidance on Established ...[ Price : $8.95]
FDA issues a drug safety alert on LEO Labs Picato gel (ingenol mebutate) due to reports of severe allergic reactions and herpes zo...[ Price : $8.95]
Pfizer says two Phase 3 studies involving Trumenba (meningococcal Group B vaccine) met all primary immunogenicity endpoints in pat...[ Price : $8.95]
CDRH says that in January it will begin accepting Global Unique Device Identification Database account requests from labelers of i...[ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 4/2 on patient-focused drug development for breast cancer.[ Price : $8.95]
FDA clears a Roxwood Medical 510(k) for the CenterCross Catheter and its use in the coronary and peripheral vasculature.[ Price : $8.95]
FDA grants accelerated approval for an AstraZeneca NDA for Lynparza (olaparib) and its use in treating women with advanced ovarian...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says it is highly concerned about FDAs plans to focus on risk evaluation and ...