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Rhode Island’s settlement with the distributors was negotiated separately from a $21 billion global settlement being proposed for other states. Read More
The FDA, as part of its Drug Competition Action Plan, has released final guidance for companies preparing to submit abbreviated new drug applications (ANDAs) to the agency for generic products. Read More
The FDA has placed a clinical hold that affects five trials of Gilead Sciences’ investigational blood cancer drug, which it just acquired two years ago. Read More
The monoclonal antibodies that have shown efficacy against Omicron are Gilead Sciences’ Veklury (remdesivir) and GlaxoSmithKline’s and Vir Biotechnology’s Xevudy (sotrovimab). Read More
The FDA has issued draft guidance clarifying the regulatory requirements for collecting and providing portions of official samples of drugs, foods or cosmetics that may be needed for the agency’s analysis or any litigation involving the items. Read More
The FDA has slapped Eli Lilly with an Untitled Letter over what it calls a “misleading” and “particularly concerning” ad the company posted on Instagram for its type 2 diabetes drug Trulicity. Read More
The FDA has released draft guidance for applicants and holders of an abbreviated new drug application (ANDA) on updating their labeling after revisions to the approved labeling of a reference listed drug (RLD) on which a generic drug is based. Read More
Pfizer and OPKO Health drew a Complete Response Letter (CRL) from the FDA for their Biologics License Application (BLA) for Ngenla (somatrogon), an injectable, long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Read More