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The FDA has asked for more information on the pen injector device used in Sanofi and Zealand Pharma's IGlarLixi combination product for diabetes, and extended its review by three months, hurting its chances to be the first product of its kind on the U.S. market. Read More
A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
The FDA awarded Janssen’s esketamine a second breakthrough designation for major depressive disorder with imminent risk of suicide, adding a second potential indication for the investigational compound. Read More