European Pharmaceutical Review

FEBRUARY 21, 2023

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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The FDA Law Blog

SEPTEMBER 17, 2024

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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Labelling Adverse Reactions Dosage 59

European Pharmaceutical Review

NOVEMBER 10, 2023

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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Vaccines Adverse Reactions FDA Immunization 52

The Checkup by Singlecare

FEBRUARY 11, 2025

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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Dosage Adverse Reactions Hospitals FDA 52

The Checkup by Singlecare

DECEMBER 12, 2024

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.

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Compounding Compounding Pharmacies FDA Insurance 52

The FDA Law Blog

APRIL 7, 2025

Koblitz & Dara Katcher Levy Promotional claims do not receive the most attention with respect to FDA enforcement these days, and veterinary promotion is no exception. Further, information presented on the adverse reaction data was inconsistent with the PI.

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Vaccines FDA Adverse Reactions 64

The Checkup by Singlecare

NOVEMBER 4, 2024

The Food and Drug Administration (FDA) does not list hair loss as a side effect of Nurtec, but some people have reported hair loss or thinning while taking this drug. As of June 2024, the FDA Adverse Event Reporting System (FAERS) Public Dashboard shows 57 patient or healthcare provider reports of hair loss (alopecia) during Nurtec ODT use.

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