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Puma Biotechnology says it expects to file an NDA for neratinib for extended adjuvant treatment of HER2-positive early-stage breas...[ Price : $8.95]
FDA issues a final rule and draft guidance on drug and biological product labeling for pregnancy and lactation information.[ Price : $8.95]
FDA commissioner Margaret Hamburg discusses the improving representation of women in clinical trials.[ Price : $8.95]
FDA approves a PulmoFlow NDA for Kitabis Pak a co-packaging of tobramycin inhalation solution with a Pari LC Plus Nebulizer for t...[ Price : $8.95]
Bloomberg News reports that FDA documents show that many Indian drug manufacturers routinely delete test results showing potential...[ Price : $8.95]
Siemens Healthcare Diagnostics begins a Class 1 recall of its Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type...[ Price : $8.95]
Aptiv Solutions says the 2013 drop in medical device facility inspections by CDRH is not likely to continue into future years.[ Price : $8.95]
ContraFect Corp. submits a response to FDA that it says addresses all of the issues identified in an IND clinical hold letter on C...