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The FDA has slapped Incyte with a Complete Response Letter (CRL) for its biologics license application (BLA) for retifanlimab, the company’s intravenous PD-1 inhibitor for the treatment of certain types of anal cancer, asking for additional data to show the drug’s clinical benefit. Read More
Bristol Myers Squibb (BMS) is withdrawing from the U.S. market the indication for its immune checkpoint inhibitor Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib. Read More
A Centers for Disease Control and Prevention (CDC) expert panel has recommended continued use of the single-dose Johnson & Johnson (J&J) COVID-19 vaccine despite reports of Guillain-Barré syndrome (GBS), a neurological illness, in a small number of inoculated individuals. Read More
A jury in the U.S. District Court for the Northern District of California has ordered Novartis to pay $177.8 million to Plexxikon, a subsidiary of Daiichi Sankyo, for infringing on two of the Japanese company’s patents. Read More
A new Israeli study has found that the Pfizer vaccine provided much lower efficacy against COVID-19 infections during a four-week period when the Delta variant became prevalent in that country. Read More
The American Medical Association (AMA) is calling for the Centers of Disease Control and Prevention (CDC) to overhaul its 2016 opioid prescribing guidelines, saying they are too strict and that they hurt patients who need pain control. Read More
The city of Philadelphia and the state of Washington have rejected the recent $26 billion national opioid settlement with three major drug distributors and drugmaker Johnson & Johnson (J&J), with Philadelphia filing a lawsuit pushing back. Read More
The FDA has added some clarifications in a final guidance released yesterday for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical gases, and combination products containing a drug constituent part. Read More
Janet Woodcock has remained acting commissioner of the FDA since January rather than gaining a nomination for a permanent appointment because of a series of political difficulties, two prominent regulatory attorneys said yesterday in an FDAnews webinar. Read More