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FDA Approves 2 Merck HIV-1 Drugs

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FDA approves two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs Delstrigo and Pifeltro.

Bipartisan Prescription Safety Alert Bill

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Three House members introduce legislation to create a prescription drug safety alert system to give drug dispensers patient inform...

Researchers Urge Stricter Breakthrough Device Reviews

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Researchers say FDA should issue time-limited breakthrough device approvals with mandated period review of a devices safety and ef...

Ultragenyx Gets FDA Nod to File UX007 NDA

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FDA accepts an Ultragenyx Pharmaceutical proposal to submit an NDA for UX007 for treating long-chain fatty acid oxidation disorder...

Comments Extended for Shared REMS Guide

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Federal Register notice: FDA reopens for 14 days the comment period on its draft guidance entitled Development of a Shared System ...

4 New Analgesic Guidances Coming

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FDA commissioner Scott Gottlieb says the agency will replace a 2014 guidance on developing new pain drugs with at least four separ...

Accord Healthcare Recalls 1 Hydrochlorothiazide Lot

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Accord Healthcare recalls one lot of hydrochlorothiazide tablets USP, 12.5 mg, due to a product labeling mix up.

FDA Accepts Evolus BLA Resubmission for DWP-450

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FDA accepts for review an Evolus BLA resubmission for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as fro...

Ortho NDA Resubmission for Psoriasis Lotion

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FDA accepts for review an Ortho Dermatologics NDA resubmission for Duobrii (halobetasol propionate and tazarotene) lotion, indicat...

Drug Complex Innovative Design Meeting Pilot

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FDA launches a complex innovative design pilot program for drug clinical trials.