This approval was based on the impressive results of the registration study (Study 205), in which the once daily combination of 18 mg LENVIMA and 5 mg everolimus
Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic
"We are very pleased that FDA has granted Fast Track designation for EG-1962 for the treatment of SAH," said Brian A. Leuthner, Edge’s Chief Executive Officer. "The FDA
A severe, rare, inherited disorder of the liver, PH1 often results in kidney failure, and there are no approved therapies for the disease. The U.S. Food and Drug
"We are very pleased to progress to the Phase 2 portion of this trial evaluating FPA008 as a treatment for patients with PVNS, an orphan joint disease associated
"These preliminary agreements in principle with the DOJ and the SEC represent an important step forward towards addressing the immediate issues facing Aegerion and positioning the Company for
The collaboration between HTG and Bristol-Myers Squibb will utilize the next generation sequencing (NGS)-based HTG EdgeSeq system as a tool for use in support of Bristol-Myers Squibb’s translational
In its written response, the FDA advised Tetraphase that data from one additional positive phase 3 clinical trial will be required to support a New Drug Application (NDA)
Under the settlement and license agreement, Horizon has granted Teligent the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under
The collaboration will support the translation of novel discoveries from MSK laboratories into first-in-field microbiome therapeutics across multiple new cancer indications, where the microbiome may play a critical
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