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The FDA revoked its breakthrough therapy designation for Tonix’s posttraumatic stress disorder drug Tonmya (cyclobenzaprine HCl sublingual tablets), citing disappointing interim data from a clinical trial. Read More
The agency has also granted a priority review for Celgene’s supplemental NDA for R2 for the treatment of patients with previously treated follicular and marginal zone lymphoma. The FDA decision date for R2 is June 27, 2019. Read More
Pfizer welcomed the positive CHMP opinion as “an important step toward bringing this treatment to patients in Europe as a potential new first-line treatment option.” Read More
The recommendation “means people can benefit while more data is collected” said Meindert Boysen, director of NICE’s Center for Health Technology Evaluation. Read More