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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Several indications were either voluntarily withdrawn by the manufacturers or recommended for withdrawal by the agency’s Oncologic Drugs Advisory Committee.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the challenges sponsors face in standardizing study data taken from real-world data (RWD) sources and issued draft guidance for sponsors including RWD as study data in their requests for clinical trial authorization.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
The Institute for Clinical and Economic Review (ICER) issued its final word on two treatments for the autoimmune disease Myasthenia Gravis (MG), saying both are useful medically but need colossal price reductions in order to make them at all affordable. Read More
The House of Representatives passed a bill in a bipartisan 368-56 vote late Tuesday that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process. Read More
In the last 10 months, the FDA evaluated drugs on the market for 10 cancer indications after having granted them accelerated approval (AA) based on surrogate endpoints, and eventually found that the drugs had a confirmed lack of benefit in several indications — but not before Medicare spent $224 million on them from 2017 to 2019. Read More
The FDA is poised to authorize booster shots of Moderna’s and Johnson & Johnson’s COVID-19 vaccines and may also allow a “mix and match” approach. Read More
Lawsuits seeking to force hospitals to administer ivermectin to COVID-19 patients show no signs of slowing in recent weeks — despite repeated warnings by regulators against such use. Read More
Any changes made in a unit operation of continuous manufacturing may have a direct and often immediate impact on downstream and upstream operations, the agency said. Read More