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FDA approves a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgens Enbrel (etanercept).[ Price : $8.95]
FDA accepts for review a CSL Behring BLA for its low-volume subcutaneous CSL830 (C1-esterase inhibitor (C1-INH) human) replacement...[ Price : $8.95]
FDA posts a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their ...[ Price : $8.95]
Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Risperidone.[ Price : $8.95]
House Energy and Commerce Committee leaders write FDA asking for details on what the agency can do to expedite generic copies of M...[ Price : $8.95]
FDA posts a final guidance on Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to D...[ Price : $8.95]
Federal Register Notice: FDA withdraws approval of eight Elanco Animal Health new animal drug regulations.[ Price : $8.95]
FDA posts a draft guidance on Bioequivalence Recommendations for Risperidone that outlines recommended bioequivalence testing for ...