Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Thus, the biosimilar presented a similar efficacy to the reference product.

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Food and Drug Administration FDA Safety Insurance 52

European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval.

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Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. Safety data for up to two years is included in the analysis. diff recurrence). “The

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Safety Food and Drug Administration Prospecting Food 95

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Potential sources include ongoing prospective studies such as patient registries, retrospective data from medical charts, control populations from previous trials and expert opinion.

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Food and Drug Administration Patients Distribution FDA 110

European Pharmaceutical Review

DECEMBER 16, 2022

In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). The gene therapy was recently approved by the US Food and Drug Administration (FDA). Safety data from the haemophilia B Phase III trial. IU/yr/participant to 8486.6

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Food and Drug Administration Safety Patients Leads 80

Pharmaceutical Technology

MAY 30, 2023

In January, the oral SERD Orserdu made waves by becoming the first approved drug to treat patients with estrogen receptor (ER)+, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with ESR1 mutations. months, versus 1.87 months on standard of care (SOC) (HR 0.518; 95% CI: 0.216-1.165).

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Patients Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time.

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FDA Food and Drug Administration Prospecting Food 59