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FDA OKs Tryvio as Add-on for Hypertension

[ Price : $8.95]

FDA approves an Idorsia NDA for Tryvio (aprocitentan) for treating hypertension in combination with other antihypertensive drugs i...

Criteria on Difficult Compounding Lists

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Federal Register notice: FDA proposes to establish criteria for the lists of drug products or drug categories that present demonst...

J&Js Edurant PED Approved for Pediatric HIV-1

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FDA approves Johnson & Johnsons Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies in...

Panel to Discuss Non-invasive Ocular Pump

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FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lo...

Key Patient Long Covid Meeting Themes

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FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.

Disease Awareness Ads Can Confuse: FDA Study

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CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and conflate product benefits and ...

Digital Health Research Grants Available

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FDA solicits applications for grants to explore the role of digital health technologies in evaluating new drugs.

FDA to Make Compounding Difficulty Lists

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FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three cate...

Bipartisan Bill to Shore Up Emergency APIs

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Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) use...

FDA Withdraws NDA/NADA for Helium

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Federal Register notice: FDA withdraws approval of an Air Products and Chemicals NDA and new animal drug application for medical g...