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FDA Alert on Compounding Remdesivir for Covid

[ Price : $8.95]

FDA urges drug compounders not to compound drug products using any remdesivir active pharmaceutical ingredient due to its complex ...

Ellodi Pharma Gains Fast Track for Eosinophilic Esophagitis

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FDA grants Ellodi Pharmaceuticals a fast track designation for APT-1011 (fluticasone propionate) oral disintegrating tablet for tr...

Accelerated Approval for TG Therapeutics Ukoniq

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FDA grants TG Therapeutics accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase...

Topics from GDUFA 3 Reauthorization Meeting

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FDA releases a summary of the 12/17/20 GDUFA reauthorization meeting.

Woodcock Addresses Covid Variants Impact on Products

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FDA Acting commissioner Janet Woodcock says FDA is developing guidances for developers of Covid-19 diagnostics, therapeutics and v...

FDA Reviewers Question Keytruda Breast Cancer Study

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FDA reviewers take issue with a Merck study supporting a new indication for Keytruda (pembrolizumab) for treating patients with hi...

De Novo Granted for Snoring/Sleep Apnea Device

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FDA grants a Signifier Medical Technologies de novo request to permit the marketing of a new prescription-only device, eXciteOSA, ...

EUA Revised to Limit Convalescent Plasma Use

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FDA limits the emergency use authorization for Covid-19 convalescent plasma after evaluating the most recent information available...

BMS Gets Liso-cel Approval for Lymphoma

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Bristol-Myers Squibb wins BLA approval for (Breyanzi) lisocabtagene maraleucel (liso-cel), indicated for treating adults with rela...

Apotex Recalls Enoxaparin Sodium Injection

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Apotex recalls two batches of enoxaparin sodium injection due to a packaging error resulting in some syringe barrels being mislabe...