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J&J Seeks Tremfya Crohns Indication

[ Price : $8.95]

Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.

De Novo for Onkos Implant Antibacterial Coating

[ Price : $8.95]

FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants.

FDA OKs New Skyrizi Indication

[ Price : $8.95]

FDA approves a new ulcerative colitis indication for AbbVies Skyrizi.

Target Health ANDA Withdrawals Notice Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target...

Human User Safety in Animal Drugs Guidance

[ Price : $8.95]

FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.

Synapse Labs Studies Unacceptable: FDA

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FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse La...

Praise, Suggestions for RWE Studies Guidance

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Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...

Medical Gas GMP, Safety Reporting Rule

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Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing ...

Clinical Hold on Zentalis Drug After 2 Deaths

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FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed s...

Elixir Breakthrough Status for Coronary Bioadapter

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FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bi...