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The FDA issued a warning letter to an over-the-counter (OTC) drugmaker in Gujarat, India for serious violations of current good manufacturing practices. Read More
Moderna said its COVID-19 vaccine offered strong protection against infection in adolescents ages 12 to 17 years in a phase 2/3 study, paving the way for the company to seek a revised Emergency Use Authorization that covers this population. Read More
The UK’s Competition and Markets Authority (CMA) is looking into whether AstraZeneca’s proposed $39 billion buyout of Boston, Mass.-based Alexion Pharmaceuticals would stifle competition. Read More
The FDA may decline to review COVID-19 vaccine Emergency Use Authorization (EUA) requests from drugmakers who neglect to meet with the agency during product development, the agency said in a revised guidance released yesterday. Read More
Drug safety surveillance, which saw a massive workload increase at the FDA’s Center for Drug Evaluation and Research (CDER) during the pandemic, hopes to pick up additional funding in the fiscal 2022 budget, said recently appointed center director Patrizia Cavazzoni. Read More
The FDA is still working out details of a regulatory pathway for bispecific antibodies, but the agency has issued a guidance for developers that says, generally, the manufacturing processes should follow “standard monoclonal antibody development practices.” Read More
Takeda Pharmaceutical’s dengue vaccine candidate, TAK-003, offered strong continued protection against dengue fever, especially infection requiring hospitalization, for up to three years with no significant safety risks, according to a late-stage study. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voiced support for approving Sanofi’s and Regeneron’s monoclonal antibody Libtayo (cemiplimab) for advanced nonsmall-cell lung cancer (NSCLC) and advanced basal cell carcinoma. Read More
FDA and industry are going back to the drawing board on proposals for safety labeling updates, according to the latest GDUFA III meetings, which also included discussions on supplement reviews and continued talks on proposals for data and technology modernization, among other topics. Read More