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July 20, 2021

FDA Requests Removal of Warning Against Statin Use in Pregnant Individuals

July 20, 2021 – The U.S. FDA has requested that statin manufacturers remove a contraindication from their products’ prescribing information
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July 20, 2021

First FDA-Approved Medication for Rare Liver Disorder Launched

July 20, 2021 – Albireo Pharma’s BylvayTM (odevixibat) has become the first drug approved by the U.S. FDA to treat pruritus in individuals who are at least three months
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July 20, 2021

Octagam Receives Indication for Rare Disease of the Muscle Tissues

July 20, 2021 – The U.S. FDA has approved a new indication for Octagam® 10% [immune globulin intravenous (human)] to treat adult dermatomyositis, a rare inflammatory
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July 16, 2021

Prograf Becomes First FDA-Approved Drug to Prevent Organ Rejection in Adult and Pediatric Lung Transplant Recipients

July 16, 2021 – The U.S. FDA has approved an expanded indication for Prograf® (tacrolimus – Astellas Pharma)
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July 16, 2021

FDA Approves First-in-Class Treatment for Chronic Graft-Versus-Host Disease

July 16, 2021 – The U.S. FDA has approved RezurockTM (belumosudil), manufactured by Kadmon Holdings, to treat chronic graft-versus-host
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July 16, 2021

Vaxneuvance Approved to Prevent Pneumococcal Disease

July 16, 2021 – The U.S. FDA has approved VaxneuvanceTM (pneumococcal 15-valent conjugate vaccine – Merck) for active immunization to prevent invasive disease
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July 16, 2021

New Oral Treatment for Sleeping Sickness Approved

July 16, 2021 – The U.S. FDA has approved Sanofi’s fexinidazole tablets to treat both stages of sleeping sickness (human African trypanosomiasis, or HAT) caused by Trypanosoma
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July 12, 2021

FDA Requires Expanded Black Box Warning for Hydroxyethyl Starch Products Used to Treat and Prevent Hypovolemia

July 12, 2021 – The U.S. FDA is requiring an expanded black box warning for hydroxyethyl
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About Global Reach Health

Global Reach Health is a diverse group of global healthcare divisions and partners delivering healthcare solutions across the globe.

Global Reach Health administrates five separate divisions to deliver seamless cross border healthcare solutions and services for a myriad of clients around the globe including insurers, pharmacies, hospitals and clinics, assistance firms, cost containment companies, third party administrators plus public entities and private corporations.

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