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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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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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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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DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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Zunveyl Approved as New Oral Med for Alzheimer’s Disease

XTalks

Related: Eli Lilly’s Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Zunveyl’s FDA approval was based on studies showing its effectiveness and more favorable side effect profile compared to existing galantamine medications.

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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.