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FDA to Study Adherence Effect on Promotion

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion says it plans to research adherence potential and patient preference in prescriptio...

Topical Ophthalmic Drug Quality Guidance

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FDA publishes a draft guidance on quality considerations for ophthalmic drug products indicated for topical delivery in and around...

Stelara Biosimilar Gets Complete Response

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Citing inspection findings that need to be resolved, FDA sends Alvotech a complete response letter for its BLA for AVT04, a biosim...

Mekinist Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Novartis Pharmaceuticals Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were...

Info Collection on Regulatory Misconduct Allegations

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Federal Register notice: FDA sends to OMB an information collection extension entitled Allegations of Regulatory Misconduct Volunt...

3 Stakeholder Comments on FDA QTc Guidance

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PhRMA suggests that FDA revise a draft guidance on QTc labeling to incorporate an International Council on Harmonization guideline...

Lilly Plans 2024 BLA for Crohns Drug

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Reporting positive data from a Phase 3 study on mirikizumab in Crohns disease, Eli Lilly says it will seek FDA approval for the dr...

14 House Dems Want ADHD Drug Shortage Info

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Rep. Abigail Spanberger and 14 Democratic colleagues ask FDA and DEA for more information on their work to resolve shortages of AD...

FDA Lifts Hold on PepGen Study

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FDA lifts a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patie...

Fast Track for Glioblastoma Vaccine

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FDA grants MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastom...