Remove Adverse Reactions Remove Events Remove Labelling
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Therapeutic-first for cold agglutinin disease haemolytic anaemia

European Pharmaceutical Review

The approval is based on data from two Phase III clinical trials: CADENZA, a trial for adults with CAD without having had a blood transfusion in the past six months and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. CADENZA Part A trial. Headache (22.7 percent vs 10.0

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FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

The FDA Law Blog

For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. Such groupings have generally seemed to appear in labeling on an ad hoc basis, without standardization.

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Sanofi’s Sarclisa gains new US multiple myeloma indication

pharmaphorum

This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

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Is compounded semaglutide safe?

The Checkup by Singlecare

That has led to some people taking it off-label (for a non-FDA-approved use) for weight lossat least until the FDA approved Wegovy specifically for weight loss in 2021. A compounded drug is any formulation of a drug that has not been produced by its original manufacturer under an official generic or brand-name label.

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CHMP adopts positive opinion for haemophilia B gene therapy

European Pharmaceutical Review

In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). The trial is an ongoing, multinational, open-label, single-arm study evaluating the safety and efficacy of etranacogene dezaparvovec. HOPE-B trial for etranacogene dezaparvovec.

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Can you take Tums and omeprazole together?

The Checkup by Singlecare

Be sure to read the labels carefully and talk to your healthcare provider about which active ingredient may be best for you, especially if you are taking other medications or supplements at the same time. In clinical trials of omeprazole , nearly 7% of participants experienced headaches as an adverse reaction.

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How AI can help pharmacists

The Checkup by Singlecare

For example, an AI model can be used to streamline workflow, identify adverse events and drug interactions, and provide medication therapy management (MTM) services. Robotic dispensing systems help prepare prescriptions by packaging and labeling medications to improve efficiency.