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Guide on Covid-19 Drugs/Biologics

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Trea...

Aldeyra Complete Response on Dry Eye NDA

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FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treatin...

Novartis Recalls 2 Sandimmune Lots

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Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottl...

Comments Extended on Unapproved Use Guide

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Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications Fr...

Evive Bios Ryzneuta Approved by FDA

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FDA approves an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as mani...

Entrada Therapeutics DMD Drug Remains on Hold

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Entrada Therapeutics says an ongoing clinical hold against the companys Phase 1 trial of ENTR-601-44 in Duchenne muscular dystroph...

Buprenex Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to...

Covid-19 Treatment, Prevention Products Guidance

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FDA publishes an immediately-in-effect guidance on developing drugs and biologics to prevent or treat some Covid-19.

Guide on GLP Study Translation

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Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.

FDA Declines to Ban Some Music in DTC Ads

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FDA declines to ban music in all DTC ads during the presentation of risk information.