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FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developi...

4 Observations in Lupin Inspection

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FDA releases the form FDA-483 with four observations from an inspection at the Lupin drug manufacturing facility in Madhya Pradesh...

Becton Dickinson Expands Alaris Pump Recall

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Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing po...

FDA DTC Push Cites GLP-1 Drugs in 4 Letters

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FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Li...

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...

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...