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40 DTC Untitled Letters Posted by FDA

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FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it ...

Guide on Developing Drugs to Treat Erosive Esophagitis

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FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developi...

Dexcom Recalls G7 and ONE + Apps

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Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.

aTyr Pharma Reports Mixed Results in Lung Trial

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aTyr Pharma reports mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic infla...

Breakthrough Status for Gynecologic Cancer Therapy

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FDA grants Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan and its use for treating patient...

Tandem Recalls t:slim Insulin Pumps

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Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-rel...

FDA OKs Corstasis Therapeutics Edema Nasal Spray

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FDA approves a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to cong...

FDA Cites Olympia Pharma Over GMPs

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FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firms Orlando, FL manufacturin...

Krystal Wins Expanded Label for Gene Therapy

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FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), ad...

Alternative Facility Assessment Tools Guidance

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FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.