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The FDA has issued a rare warning about the multiple myeloma drug Pepaxto (melphalan flufenamide), saying a recent confirmatory trial showed an increased risk of death. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new quality guideline for sponsors of drug-device combination products that will go into effect on Jan. 1. Read More
A bipartisan group of U.S. senators has called on HHS Secretary Xavier Becerra to support policies that will allow Americans to “personally import” prescription drugs from Canada. Read More
If preliminary voting sticks, Purdue Pharma’s controversial bankruptcy plan that settles with thousands of cities and states over the company’s role in the opioid epidemic will be accepted when the final tally is made public Aug. 2. Read More
The jury award for Plexxikon also includes additional royalty payments for future sales of Tafinlar in the U.S. through the life of the patents, which expire in July 2028. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More
The FDA explained in a new Manual of Policies and Procedures (MAPP) how generic drug sponsors can get their applications approved even if the submission coincides with labeling changes to the reference drug. Read More
Endo International has agreed in principle to pay a settlement of $35 million in a Tennessee lawsuit related to alleged abuse of its opioid drugs. Read More
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