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FDA Recommends More Leqembi MRIs

[ Price : $8.95]

FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan...

FDA-483 on IntegraDose Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Servic...

Integra Recalls Surgical Applicators Over Sterility Issues

[ Price : $8.95]

Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.

Platinum Biologics Selling Unapproved New Drugs: FDA

[ Price : $8.95]

FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.

Amylyx Nixes AMX0035 Development After Failed Study

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Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in...

FDA Alert on Abiomed Impella Controllers

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FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella contr...

BioXcel Plans sNDA for At-Home Bipolar Drug

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BioXcel Therapeutics plans an early 2026 supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL50...

Innate Healthcare Illegally Marketing Stem Cells: FDA

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FDA warns Scottsdale, AZ-based Innate Healthcare Institute that it is illegally marketing adulterated and misbranded stem cell pro...

Violations in Uscom Spirometer Inspection

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FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its f...

Hikma Injectables FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing ...