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Rhythm Pharma Positive Data on Obesity Drug

[ Price : $8.95]

Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for tr...

Teva Files sBLA to Expand Migraine Therapys Use

[ Price : $8.95]

FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include p...

Device Reviews Will Now Take Longer: Shuren

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Former CDRH director Jeff Shuren says recent staff cuts at CDRH will likely lead to longer review times.

Amgens Uplizna OKd for Immunoglobulin G4 Disease

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FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related d...

Could HHS Mea Culpa Lead to FDA Rehires?

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HHS secretary Robert F. Kennedy Jr. admits that many mistakes were made in cuts across HHS health agencies, including FDA, and tha...

House Committee Hearing on Reducing FDA Inefficiencies

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The U.S. House Committee on Oversight and Government Reform announces a 4/9 hearing on reducing inefficiencies and the bureaucracy...

Marks: RFK Jr. Wants FDA to Support Stem-cell Treatments

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CBER director Peter Marks speaks out about the pressure he faced before given the option to resign or be fired for questioning HHS...

Draeger Recalls Flex 220 Breathing Circuit

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Draeger recalls its Flex 220 ID breathing circuit due to the risk of cracks forming in the breathing circuit hose.

Breakthrough Status for Uveal Melanoma Therapy

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FDA grants Ideaya Biosciences a breakthrough therapy designation for darovasertib for neoadjuvant use in adult patients with prima...

CRL for Aldeyras Reproxalap for Dry Eye

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FDA issues a complete response letter to Aldeyras NDA for reproxalap to treat dry eye disease, citing a lack of efficacy in the su...