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Lilly Latruvo BLA Approval Revoked

[ Price : $8.95]

Federal Register notice: FDA announces it is revoking approval of an Eli Lilly BLA for Lartruvo (olaratumab), indicated for combin...

Warning Sent to Web Site on Unapproved Drugs

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FDA sends a Warning Letter to the operators of www.pharmaboosters.com over marketing unapproved and misbranded drugs.

FDA Clears Ambu Single-use Duodenoscope

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FDA clears an Ambu 510(k) for its Ambu aScope Duodeno, a single-use duodenoscope.

Denovo Bio Fast Track for Enzastaurin

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FDA grants Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients wit...

De Novo Authorization for Glycemic Controller

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FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controlle...

Irradiation Regulation Repeal to Help OTC Drugs

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Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug pro...

Boston Scientific Disposable Duodenoscope Cleared

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FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.

Draft Guide on Drug Development Tools Qualification

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FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.

Amarin Gains Expanded Use for Vascepa

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FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to s...

Final Rule on Device e-Submissions

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Federal Register notice: FDA issues a final rule amending requirements for medical device premarket submissions to require a singl...