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AstraZeneca (AZ) reportedly may not file for FDA Emergency Use Authorization (EUA) of its COVID-19 vaccine until mid-May as it needs more time to gather supporting data. Read More
Moderna said it plans to produce up to 3 billion doses of its messenger RNA-based COVID-19 vaccine globally in 2022, including booster shots against viral variants and pediatric vaccines. Read More
The latest round of GDUFA III reauthorization discussions between the FDA and industry focused on facility inspections, drug master files (DMFs) and annual reporting commitments. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s arthritis drug Olumiant (baricitinib) as a possible treatment for hospitalized COVID-19 patients age 10 years and older who require supplemental oxygen. Read More
Pfizer has acquired San Diego, Calif.-based Amplyx Pharmaceuticals, broadening its portfolio of potential therapies for treating drug-resistant fungal infections. Read More
The Biden administration is implementing a Trump-era proposal that enables healthcare professionals to more easily administer the opioid addiction treatment buprenorphine. Read More
For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines. Read More
U.S. prices for nearly two dozen brand-name prescription drugs in 2020 were two to four times those seen by consumers in Australia, Canada and France, said the Government Accountability Office (GAO). Read More