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Lilly Retatrutide Meets Key Primary, Secondary Endpoints

[ Price : $8.95]

Lilly says its investigational type 2 diabetes triple agonist retatrutide met its key primary and secondary endpoints in a Phase 3...

Warning Letter Cites Right-to-Try Law

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Two Mintz attorneys say a CDRH Warning Letter to a medical device sponsor of clinical research and compassionate use protocols may...

FDA Approves First Treatment for Debilitating Itch in Liver Disease

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FDA approves GSKs Lynavoy (linerixibat), the first U.S.-authorized therapy specifically for cholestatic pruritus in patients with ...

Sarepta to Submit Amondys 45 and Vyondys 53 sNDAs

[ Price : $8.95]

Sarepta says it will submit to FDA by the end of April sNDAs to convert the accelerated approvals of its Amondys 45 and Vyondys 53...

Novo Nordisks High-Dose Wegovy Approved

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FDA approves a higher-dose version of Novo Nordisks blockbuster weight-loss drug Wegovy (semaglutide) injection.

Rare Disease Advocates Stage Funeral at FDA Headquarters

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Ultrarare disease sufferers and advocates stage a mock funeral at FDA headquarters to grieve the lack of approved treatments for c...

CSL Reports Temporary Shortage of Hemophilia B Gene Therapy

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CSL notes it is actively working with regulatory authorities to address the shortage and develop strategies to ensure a stable lon...

LivaNova PMA OKd for Sleep Apnea

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FDA approves a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat adults with moderate to severe o...

Multiple Avertix Medical Violations Cited

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FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Correction and Removal violation...

Indias Patcos Markets Insanitary OTC Drugs with CGMP Issues: FDA

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FDA warns Indias Patcos Cosmetics that it is marketing adulterated over-the-counter drug products that have significant violations...