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The designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, which studied the efficacy and safety of abemaciclib, a cyclin-dependent

The new formulation of Copaxone is anticipated to allow for a less frequent dosing regimen for patients with RRMS in the country. Teva Global Specialty Medicines president and

Under the deal, Lonza will develop a scalable manufacturing process for Benitec’s ddRNAi-based and Adeno-Associated Virus (AAV)-delivered products specified for therapeutic use in humans. Lonza will use its

In September, FDA had granted orphan drug designation for avelumab, to treat MCC, a rare and aggressive type of skin cancer. Pfizer oncology chief medical officer and clinical

Riociguat, a soluble guanylate cyclase (sGC) stimulator, has been approved since 2013 for the treatment of adults suffering from this life-threatening disorder of the lungs. The development and

Pembrolizumab is said to be the first drug to be approved in March through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme (EAMS). The

The clinical trial had 60 pre-diabetic patients. This key developmental trial, being conducted in Hong Kong and the associated endpoints are pivotal for concluding the BTI-320 registration in

The primary efficacy endpoint is the summed pain intensity difference (SPID) over 1-hour (SPID1). Safety endpoints, such as adverse events and vital signs will also be assessed, as

The sNDAs can be used for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis),