We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is outperformed by the European Medicines Agency (EMA) and Health Canada when it comes to proactively releasing data on drug approvals, says a new study ― prompting concerns about the FDA’s relative transparency. Read More
In January 2020, the FDA issued a notice inviting the drugmakers to petition the agency for a hearing in which they could explain why their ANDA applications shouldn’t be withdrawn. Read More
As Congress races to finalize details on President Biden’s signature social spending package by week’s end, a provision allowing Medicare to negotiate prescription drug prices is expected to stay in the bill, but likely in a diluted form. Read More
Pfizer/BioNtech’s pediatric vaccine was safe and 90.7 percent effective against symptomatic COVID-19 in children ages five to 11 even when up against the Delta variant over the summer. Read More
Last month, Walensky overrode the recommendations of the advisory committee, which supported a Pfizer/BioNTech COVID-19 booster, but not for adults at high risk of contracting the disease in the workplace. Read More
Effective Nov. 21, the FDA is pulling the approvals of 216 abbreviated new drug applications (ANDAs) as it cracks down on drug sponsors who have failed to submit the required annual reports. Read More
Pfizer/BioNtech’s pediatric vaccine was safe and 90.7 percent effective against symptomatic COVID-19 in children ages five to 11 even when up against the Delta variant over the summer. Read More
Several indications were either voluntarily withdrawn by the manufacturers or recommended for withdrawal by the agency’s Oncologic Drugs Advisory Committee. Read More
The FDA has acknowledged the challenges sponsors face in standardizing study data taken from real-world data (RWD) sources and issued draft guidance for sponsors including RWD as study data in their requests for clinical trial authorization. Read More
The White House has secured 28 million doses of the Pfizer-BioNTech pediatric COVID-19 vaccine and plans to roll out the jabs for kids age five to 11 as soon as the FDA and Centers for Disease Control and Prevention (CDC) give the go-ahead for vaccines in that age group. Read More