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August 16, 2021

Welireg Approved for Genetic Condition Tied to Tumor Growth

August 16, 2021 – The U.S. FDA has approved Merck’s WeliregTM (belzutifan), the first hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor to become
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August 13, 2021

Mirena Receives Expanded Approval for Contraception

August 13, 2021 – The U.S. FDA has expanded approval for Mirena® (levonorgestrel-releasing intrauterine system), an intrauterine device (IUD) manufactured by Bayer, to prevent pregnancy
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August 13, 2021

TicoVac Wins U.S. FDA Approval to Prevent Tick-Borne Encephalitis

August 13, 2021 – TicoVacTM (tick-borne encephalitis vaccine), manufactured by Pfizer, has received FDA approval to provide active immunization to prevent
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August 12, 2021

FDA Grants First Drug Approval for Uncommon Sleep Disorder

August 12, 2021 – The U.S. FDA has approved a new indication for Xywav® (calcium/magnesium/ potassium/sodium oxybates) oral solution
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August 12, 2021

Durezol Generic Launched, Approved to Treat Eye Inflammation

August 12, 2021 – Cipla has received final approval from the U.S. FDA for its generic version of Durezol® (difluprednate ophthalmic emulsion – Novartis) 0.5%.
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August 12, 2021

Moderna, Pfizer/BioNTech COVID-19 Vaccines Authorized for Use as Booster Shots for Immunocompromised Individuals

August 12, 2021 – The U.S. FDA has modified the emergency use authorization (EUA) for both the Pfizer
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August 10, 2021

Sodium Bicarbonate for Injection Recalled to Hospital Pharmacy Level

August 10, 2021 – SterRx, LLC, has recalled three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000mL to the hospital pharmacy level as a result of waterborne
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August 6, 2021

New Enzyme Replacement Therapy Approved for Pompe Disease

August 6, 2021 – The U.S. FDA has approved Sanofi’s Nexviazyme® (avalglucosidase alfa-ngpt), to treat late-onset Pompe disease (LOPD) in patients who are at least a year old.
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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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