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AnaptysBio Reports Positive Data on Arthritis Drug

[ Price : $8.95]

AnaptysBio reports positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis.

Max Mobility Recalls Wheelchair Speed Control Dial

[ Price : $8.95]

Max Mobility recalls its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board...

Strukmyer Medical CGMP Violations

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FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.

Chengdu Records Review Finds CGMP Deviations

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FDA warns Chinas Chengdu Innovation Pharmaceutical Co. about CGMP deviations in manufacturing active pharmaceutical ingredients.

Court Orders FDA to Restore Gender Web Pages

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DC federal judge John Bates orders FDA and CDC to re-post Web pages and datasets they removed to comply with President Trumps exec...

Change FDA Approach to Antibiotic Approval: Column

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A STAT First Opinion column calls on FDA to focus on how effective new antibiotics are in real-world patients, rather than approvi...

Biohaven NDA Filed for Spinocerebellar Ataxia Drug

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FDA accepts for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia.

Breakthrough Status for Knee Arthritis Device

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FDA grants Guerbet a Breakthrough Device Designation for LipioJoint, a liquid embolic agent designed to alleviate pain in patients...

SpringWorks Gomekli Approved for Neurofibromatosis

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FDA approves a SpringWorks Therapeutics NDA for Gomekli (mirdametinib) for treating certain patients with neurofibromatosis Type 1...

Regeneron BLA Resubmitted for Multiple Myeloma

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FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/re...