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Medical Gas GMP Requirements Amended

[ Price : $8.95]

Federal Register notice: FDA proposes new regulations that would amend the requirements on current good manufacturing practices an...

GI Advisory Committee Renewal Notice Correction

[ Price : $8.95]

Federal Register notice: FDA corrects a 5/11 notice entitled Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewa...

More Women Participating in Clinical Trials: Report

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FDA principal deputy commissioner Janet Woodcock and two other FDAers praise agency efforts to increase participation of women in ...

FDAers Discuss PBBM Overview and Future

[ Price : $8.95]

Three FDAers and a drug researcher give an overview of physiologically-based biopharmaceutics modeling.

ImmunityBio BLA for Bladder Cancer Therapy

[ Price : $8.95]

ImmunityBio files a BLA for N-803, which it describes as a first-in-class IL-15 superagonist, plus Bacillus Calmette-Gurin (BCG) f...

Companies Say Pfizer Covid Booster Effective in Young Kids

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Pfizer says a Covid vaccine booster shot was effective in kids 6 months to under age 5.

Companies Push New Formulations for Blockbusters

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Researchers say drug companies are more likely to seek new formulations for blockbuster products and those given accelerated appro...

EMA Recommends Suspending Generics Tested by Synchron

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A European Medicines Agency committee says authorization of several generic medicines should be suspended because of questions abo...

FDA Denies Tyvaso DPI Petition

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FDA denies a petition asking for restrictive agency actions on an NDA for Tyvaso.

CorneaGen Recalls 1 Lot of Scleral Patch Grafts

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FDA provides information on a CorneaGen recall of one lot of scleral patch grafts.