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Eli Lilly Thursday scored its second court victory in less than a week and third overall in lawsuits against its blockbuster antidepressant Cymbalta. Read More
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. Read More
The FDA has extended until Nov. 27 its deadline for deciding whether to approve Bristol-Myers Squibb’s sBLA for Opdivo in previously untreated advanced melanoma to allow the company to present additional data from a Phase 3 clinical trial. Read More
AbbVie said it will seek FDA approval later this year for its investigational leukemia treatment venetoclax, after the drug met its primary goal in a Phase 2 trial. Read More
A Houston, Texas, API and finished drugmaker received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More