Novartis unit Sandoz is seeking approval for the similar indication as the reference product. The company said the totality of evidence in its submission, including three clinical trails,
Farletuzumab is an investigational humanized monoclonal antibody (mAb) that binds to folate receptor alpha, a protein which is highly expressed in ovarian carcinoma but largely absent from normal
Cebranopadol is a novel, first-in-class analgesic in development for the treatment of moderate to severe chronic nociceptive and neuropathic pain and is an important addition to Depomed’s leading
The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the
The acquisition bolsters LGC’s growing portfolio of reference materials and proficiency testing (PT) schemes for the clinical market. LGC’s Standards Division managing director Euan O’Sullivan said: "We are
The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing duvelisib with
Immune CEO Daniel Teper said: "We recently announced U.S. IND acceptance by the FDA for bertilimumab in bullous pemphigoid, and today, with our first patient enrollment in ulcerative
The PAREXEL Clinical Development Optimization process uses advanced technology to help expedite drug development through all four critical stages of clinical development – design, start-up, trial execution, and
Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used in combination with
Turing head of research and development Eliseo Salinas said: "I’m happy to report that TUR-004 was well tolerated and assessments continue as planned. "This is certainly a small
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.