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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Experts say that the Singulair incident highlights a flawed system, both in the U.S.

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FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

LifeProNow

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.

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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.

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First-in-class phosphate absorption inhibitor approved by FDA

European Pharmaceutical Review

However, in the trials, the only observed adverse reaction for the treatment was diarrhoea. Most XPHOZAH-treated patients experienced mild-to-moderate reactions that resolved over time, or with dose reduction. XPHOZAH is expected to be available to eligible patients in the US in November 2023.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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US FDA approves Incyte’s merkel cell carcinoma therapy

Pharmaceutical Technology

The approval from the FDA was based on the data obtained from the multiregional, open-label, single-arm POD1UM-201 trial, conducted in metastatic or recurrent locally-advanced MCC adults who did not receive systemic therapy previously for their advanced disease. Partial response was seen in 22 patients and complete response in 12 patients.

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FDA Proposes Streamlined Medication Handouts

PharmExec

New program seeks to reduce misuse and adverse reactions by simplifying prescription labels.