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To help support a global approach to developing new drugs that address antimicrobial resistance (AMR), the European Medicines Agency (EMA) has published a final guideline aimed at aligning data requirements with other countries to meet multiple regulators’ needs. Read More
To help small entities follow its 2020 final rule on importing prescription drugs from Canada, the FDA released a compliance guide yesterday explaining that U.S. importation programs must show “significant cost reductions” of the products to American consumers. Read More
West Chester, Pa.-based Verrica Pharmaceuticals drew a second Complete Response Letter (CRL) from the FDA rejecting the company’s New Drug Application (NDA) for its investigational drug VP-102 to treat patients with the viral skin disease molluscum contagiosum. Read More
Best-selling medicines and drugs cleared under an FDA accelerated approval nab the most FDA-approved new formulations, and this translates to more costs for insurance plans and patients, according to an analysis in the journal JAMA Health Forum. Read More
SpringWorks unveiled some good news this week with positive topline data supporting its investigational antitumor drug nirogacestat in patients with progressing desmoid tumors. Read More
A federal judge in Delaware has ended an attempt by Gilead Sciences to defend its Lexiscan (regadenoson) cardiac stress agent from generic competition. Read More
In an unusual legal action, Vanda Pharmaceuticals is suing the FDA in a federal court for denying a request for Fast-Track designation for its investigational drug tradipitant after a series of failed attempts using other regulatory pathways. Read More