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The randomized phase 2 clinical trial, dubbed PINNACLE, featured 145 patients. Tarextumab was administered in combination with etoposide plus either cisplatin or carboplatin chemotherapy in patients who were previously untreated for

The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 741 and affects nearly

Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen. ODAC is

According to the company, emicizumab prophylaxis demonstrated a clinically meaningful reduction in the number of bleeds over time at this interim analysis after a median of 12 weeks

Supported by data from five clinical studies involving 660 patients, IBI is seeking FDA marketing approval of Dexycu as a long-acting dropless treatment for inflammation associated with cataract

The company’s novel therapeutic oral delivery platform has the potential to transform patient care by improving therapeutic efficacy, reducing side effects, and generating cost-savings to patients and healthcare

The regulator stated that the NDA requires additional clinical data to determine the most appropriate doses of the once-daily oral medication. In addition, the FDA said additional data is required

The Company has received initial regulatory approvals in Europe to initiate the ZENITH-1 exploratory clinical trial this summer. Jon Stonehouse, Chief Executive Officer said: "To complement the attractive

The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention