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FDA approves first treatment for geographic atrophy

European Pharmaceutical Review

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. A marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.

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OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024

The FDA Law Blog

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.

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First chikungunya vaccine approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. Valneva declared it plans to begin commercialisation of IXCHIQ in the US in early 2024. The vaccine was granted PRIority MEdicine (PRIME) designation by the EMA in 2020.

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Victoza generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2010. More recently, in December of 2024, Victoza became the first authorized generic once-daily GLP-1 injection to lower blood sugar. He added, Then, in December 2024, Hikma Pharmaceuticals introduced a generic liraglutide product after receiving FDA approval.

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Wegovy side effects and how to avoid them

The Checkup by Singlecare

For anyone considering Wegovy, its important to know all the potential adverse reactions before starting treatment, plus how to avoid and manage them. A study in Obesity Reviews from 2024 found that semaglutides adverse effects were typically mild or moderate, not serious. Fortunately, weve got all that info right here.

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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. Unicycive plans to resolve FDA concerns by utilizing a second manufacturing vendor with a successful regulatory history to address manufacturing-related issues. 1 REFERENCES 1.

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Is compounded semaglutide safe?

The Checkup by Singlecare

In fact, the Food and Drug Administration (FDA) says consumers should exercise a lot of caution when considering using a compounded drug. Ozempic is arguably the most popular semaglutide drug, not because of its FDA-approved use for treating Type 2 diabetes but because of the amount of weight people have lost while taking it.