Myalept, an analogue of leptin made through recombinant DNA technology, is the first and only treatment approved by the FDA for these patients. The company is currently working
Gevokizumab is a potent monoclonal antibody with an allosteric modulating properties and the potential to treat patients with a variety of inflammatory and other diseases. It binds strongly
The new JV will produce and dispense legal medical cannabis to Health Canada patients in British Columbia. CanMED expects to complete the licensing process in the next few
Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, with a target action date of
As part of the deal, Ardelyx would also be eligible to get royalties on product sales as well as retain an option to participate in co-promotional activities for
The marketing approval of Ruconest is for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Ruconest (conestat alfa) is a recombinant human C1 esterase
Metabolon has signed several research collaboration and licensing agreements with Patia Biopharma related to use of Metabolon’s Quantose IR technology, a blood test for prediabetes that reflects insulin
The breakthrough therapy designation is based on data from the company’s ongoing Phase III clinical trial program that is evaluating the all-oral combination regimen of DCV, an investigational
DuoResp Spiromax is indicated for the treatment of COPD patients when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. The CHMP decision creates a path forward
Provided under the 2012 US Generating Antibiotic Incentives Now (GAIN) Act, the QIDP designation allows the company to have priority review, eligibility for fast-track status, and an additional
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