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Par Pharmaceutical’s efforts to litigate its way to a generic version of Adderall XR ended with a whimper Tuesday, after a federal judge barred the company from challenging Shire’s patents on the drug. Read More
With a mixed bag of results and much at stake for BioMarin’s Duchenne muscular dystrophy treatment drisapersen, FDA reviewers overwhelmingly decided the largest, most complete trial in the drug’s development weakened “promising” findings from earlier studies. Read More
Eli Lilly scored an FDA approval Tuesday for EGFR inhibitor Portrazza in combination with chemotherapy for second-line treatment in metastatic squamous non-small cell lung cancer. Read More
Two senators are pressing the Department of Health and Human Services to authorize prescription drug importation from Canada to combat price gouging in the marketplace. Read More
On Tuesday, the FDA released the Oct. 22 warning letter issued to Sandoz sites in Kalwe and Turbhe, Maharashtra, India, which Sandoz had earlier hinted at during its third quarter earnings call. With the release of the warning letter, the extent of the data integrity issues are now known. Read More