Pharmacy Times

MAY 17, 2023

Pegfilgrastim-pbbk is a leukocyte growth factor developed to reduce the onset of infection in patients with non-myeloid malignancies administered myelosuppressive anticancer medications associated with a clinically significant rate of febrile neutropenia.

Medical 52

Medical Patients 52

Pharmaceutical Technology

JANUARY 13, 2023

Enhertu’s safety profile was consistent with the previous clinical trials. Diarrhoea, decreased appetite, constipation, fatigue, musculoskeletal pain, neutropenia, vomiting, anaemia, leukopenia, thrombocytopenia, increased transaminases, nausea, and alopecia are the most common adverse reactions observed in the trial.

Engineering 128

Engineering Safety Patients Medicine 128

Pharmaceutical Technology

MARCH 1, 2023

The regulatory approval is based on the data obtained from the randomised Phase III SAPHYR clinical trial, which was conducted in steroid-resistant active PMR patients. The trial met its primary endpoint, with 28% of patients treated with Kevzara achieving sustained remission compared to 10% for placebo at 52 weeks.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

European Pharmaceutical Review

NOVEMBER 4, 2022

First, they are associated with a variety of toxicities, including neutropenia, neuropathy, hypersensitivity, alopecia and gastrointestinal issues. Potential of oral taxanes and initial outcomes in the clinic. However, severe neutropenia and some gastrointestinal toxicities were worse compared to q3w IV paclitaxel.

Food and Drug Administration 86

Food and Drug Administration FDA Pharmaceutical Patients 86

Pharmaceutical Technology

FEBRUARY 27, 2023

The regulatory approval is based on the data obtained from the open-label, head-to-head, randomised, international Phase III DESTINY-Breast03 clinical trial. In the study, Enhertu showed a 72% reduction in the risk of disease progression or death compared to T-DM1 and a consistent safety profile with previous clinical trials.

Safety 52

Safety Engineering Physicians Patients 52

pharmaphorum

NOVEMBER 25, 2022

In review documents published ahead of the ODAC meeting, the agency took issue with what it described as marginal efficacy in clinical trials of the drug, high toxicity rates, and concerns about the dose selected for study. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

FDA 95

FDA Side effects Prescription Recruitment 95

Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. The most common Grade ≥3 treatment-related adverse events were neutropenia at 20%, hypertension at 3%, and hemorrhage.

FDA 59

FDA Patients Safety Pharmaceutical 59