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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
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
The WHO granted the vaccine an emergency use listing (EUL) in November 2021 but suspended the supply in April following its inspection of the Bharat Biotech facility. Read More
The FDA sent a warning letter to Newbury Park, Calif.-based Colorful Products citing serious quality control violations at the company’s over-the-counter (OTC) drug manufacturing facility. Read More
The FDA approved Sanofi and Regeneron’s blockbuster monoclonal antibody, Dupixent (dupilumab), for patients 12 years and older with eosinophilic esophagitis, a rare chronic inflammatory disorder — making it the first FDA-approved treatment for the disease. Read More
About 100 generic medicines are likely to get their European marketing authorizations yanked following revelations of flaws in their bioequivalence studies conducted at one particular contract research organization. Read More