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FDA Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

Health care workers and nursing home residents and staff should get the initial shots, according to guidelines issued recently by a U.S. The nursing home industry applauded the approval. The association represents 14,000 nursing homes and assisted living facilities. ” Who is first in line to be vaccinated?

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FDA approves Abbott’s rapid portable COVID-19 test

The Pharma Data

.” This follows the FDA granting Emergency Use Authorization back in March to Abbott’s ID NOW rapid molecular test that can provide results in 30 minutes and can be used in doctor’s office labs and nursing homes. . The new test is different as it uses a companion mobile app for iPhone and Android to quickly display the results.

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Tarpeyo (Budesonide) Is Transforming IgA Nephropathy Care with FDA’s Full Approval

XTalks

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease

XTalks

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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On Speakers Programs and PhRMA’s Updated Ethics Code

Intouch Solutions

new medical or scientific information or a new FDA-approved indication for the product) or the importance of the availability of such educational programming.” What our audiences want is time – time is more valuable than a fancy dinner.

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How the US’s pending PIE Act will improve patient access to medication

pharmaphorum

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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FDA green lights Oxehealth vital signs monitoring software

pharmaphorum

UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates from a camera feed. . The approval means the Oxford University spin-out can place Oxevision on the market in all US states.

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