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Califf Adds 2 Senior Officials to Leadership Team

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FDA commissioner Robert Califf taps former Johns Hopkins School of Medicine professor Namandj N. Bumpus as the agencys new chief s...

Sentators Urge FDA to Allow OTC Hearing Aids

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Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) urge FDA to finalize a proposed rule on making certain hearing aids ava...

Comments on OPDP Research Proposal

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Three drug company stakeholders suggest changes to research proposed by the CDER Office of Prescription Drug Promotion.

2 Drugs Have Positive Effect on Alzheimers Disease: Study

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University of Colorado researchers say they have identified two FDA-approved drugs that may help prevent Alzheimers disease and im...

Breakthrough Designation for Janssens Talquetamab

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FDA grants breakthrough therapy designation to Janssens talquetamab for some multiple myeloma patients.

Fit-For-Purpose Clinical Outcome Assessment Guidance

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FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health th...

FDA Determines Regulatory Review Period for Rukobia

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Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia ...

Regulatory Review Period for Danyelza

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Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics ...

FDA Will Review Eylea sBLA for an Extended Dosing Regimen

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FDA sets 2/28/23 as the target date for its review of a Regeneron sBLA for a 167-week dosing regimen of Eylea in patients with dia...

Attorneys See Renewed DoJ Interest in Fraud-on-FDA

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A Duane Morris legal alert says the Justice Department is showing a renewed interest in fraud-on-FDA cases.