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FDA Approves Sandoz Biosimilar for Enbrel Copy

[ Price : $8.95]

FDA approves a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgens Enbrel (etanercept).

FDA Accepts CSL Behring BLA for Hereditary Angioedema Attacks

[ Price : $8.95]

FDA accepts for review a CSL Behring BLA for its low-volume subcutaneous CSL830 (C1-esterase inhibitor (C1-INH) human) replacement...

FDA Finalizes Rule to Require Electronic Drug Registration/Listing

[ Price : $8.95]

FDA posts a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their ...

Guidance on BE Recommendations for Risperidone

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Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Risperidone.

Commerce Committee Asks FDA How to Expedite EpiPen Generics

[ 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...

FDA Guidance on Enforcement Discretion on Device Codes

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FDA posts a final guidance on Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to D...

FDA Withdraws 8 Elanco NADAs

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Federal Register Notice: FDA withdraws approval of eight Elanco Animal Health new animal drug regulations.

FDA Draft Guidance on Risperdal Bioequivalence Studies

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FDA posts a draft guidance on Bioequivalence Recommendations for Risperidone that outlines recommended bioequivalence testing for ...

Cook Medical Class 1 Recall of Roadrunner Wire Guides

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Cook Medical begins a Class 1 recall of its Roadrunner Uniglide Hydrophilic Wire Guide due to potential coating contamination with...

Mylan to Launch EpiPen Authorized Generic to Curb Criticism

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Faced with mounting criticism over its costly EpiPen Auto-Injector (epinephrine injection), Mylan now says it will launch an autho...