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FDA OKs Janssen Biotechs Subcutaneous Darzalex Faspro

[ Price : $8.95]

FDA approves a Janssen Biotech BLA for subcutaneous Darzalex Faspro for adult patients with newly diagnosed or relapsed/refractory...

BMS Files NDA for Leukemia Drug

[ Price : $8.95]

FDA accepts for review a Bristol Myers Squibb NDA for CC-486, an investigational oral hypomethylating agent for the maintenance tr...

Covid-19 to Spur Wide Vaccines Growth: Alliance

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Alliance for a Stronger FDA says the vaccines development industry is likely to see a renaissance under pressure from the Covid-19...

FDA Green Lights Remdesivir for Covid-19 Emergency Use

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FDA grants Gilead Sciences an emergency use authorization for its antiviral drug remdesivir for treating suspected or laboratory-c...

Comments on FDA Data Strategy

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Three stakeholders comment for the FDA docket on updating the agency data strategy.

New Safety Signal MAPP

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CDER issues a MAPP on its approach to newly identified safety signals in marketed drugs.

Info Collection on Combo Product Constituent Parts

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Federal Register notice: FDA seeks comments on an information collection extension entitled Information Sharing Among Constituent ...

Guide on Accredited Third-Party Certification Program

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Federal Register notice: FDA makes available a final guidance entitled Temporary Policy Regarding Accredited Third-Party Certifica...

Ophthalmic Devices Panel Meeting Postponed

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Federal Register notice: FDA postpones a 6/9-planned Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting th...

Court Orders Halt to Covid Silver Product Sales

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The Utah federal court orders two companies and their owner to stop selling silver products as a preventive or treatment for Covid...