Based on the anticipated Prescription Drug User Fee Act (PDUFA) action date, the FDA approval is expected in the second quarter of 2015. The sNDA was based on
The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA)for Lamivudine Tablets to treat chronic hepatitis B virus
Based upon the COMP positive opinion, the commission will make a final decision on European orphan drug designation. BCX4161 is a selective inhibitor of plasma kallikrein and is
The Nucynta franchise includes Nucynta ER (tapentadol) extended release tablets that are designed to manage pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), and Nucynta (tapentadol),
As part of the agreement, Vical will develop and provide a DNA vaccine encoding the glycoprotein antigen of the 2014 Zaire strain of Ebola virus to AnGes, which
Incruse is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator which can relax airway muscles and improve airflow in and out of the lungs. GSK Medical Director
The collaboration comes with the possibility of a one-year extension and will be focused on the development of new mRNA-based treatments and vaccines against four undisclosed viruses. As
Myalept is a recombinant human leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or
The ongoing multi-center, open label dose escalation BP-004 trial is being held at leading transplant centers in Europe and in the US. Phase I arm of the trial
As part of the deal, the research capabilities of the two parties will be brought together to identify new immune-modulatory agents for oncology, autoimmune and respiratory disorders. In
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