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FDA Alert on BD Covid-19 Reagents

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An FDA safety alert warns about an increased risk of a false positive result with Becton Dickinsons BD SARS-CoV-2 Reagents for the...

Guide on Device UDI Compliance Dates

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Federal Register notice: FDA makes available a guidance on Unique Device Identification Compliance Dates for certain dates.

FDA Approves Genentechs Phesgo for Breast Cancer

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FDA approves Genentechs outpatient breast cancer drug Phesgo.

Draft Guide on Anti-Infective Drug Products

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Federal Register notice: FDA makes available a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatr...

FDA Approves New Indication for Mercks Keytruda

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FDA approves a new indication for Mercks Keytruda to treat specified forms of colorectal cancer.

Anti-Infective Pediatric Drug Development Guidance

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FDA publishes a draft guidance with general recommendations for sponsors developing anti-infective drug products for pediatric pat...

FDA Stresses High Standards for Coronavirus Vaccine

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FDA issues an immediately effective guidance for developers of Covid-19 vaccines saying any vaccine should be effective in at leas...

Avoid Hand Sanitizers with Methanol: FDA

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FDA reiterates warning against hand sanitizers containing methanol.

FDA Rejects Intercepts NASH Drug

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Endpoint News reports that FDA has rejected an Intercept Pharmaceuticals NDA for its obeticholic acid to treat NASH.

FDA Approves Rukobia for Some HIV Patients

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FDA approves ViiVs Rukobia for certain HIV patients.