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The buzz at the Drug Information Association’s (DIA) annual meeting — being held in person this week in Chicago after two “virtual” years — is focused largely on user fee reauthorization as a legislative package makes its way through the Senate following the passage of a House version on June 8. Read More
The FDA has issued a warning letter to Hybrid Pharma — a Deerfield Beach, Fla.-based compounder — for producing adulterated drugs and failing to have any approved applications on file for the products. Read More
With positive new phase 3 interim results in hand, AstraZeneca is poised to file for regulatory approval for eplontersen, an antisense drug to treat complications of transthyretin amyloidosis (ATTR), a rare and fatal disease. Read More
If millionaire entrepreneur and television personality Mark Cuban’s online generic drug company had existed in 2020, it would have saved Medicare Part D as much as $3.6 billion, or 37 percent of the $9.6 billion spent that year on 77 of 89 different prescription drugs. Read More
The House Appropriations Committee is scheduled to mark up a fiscal 2023 FDA funding bill on Thursday that includes a 10 percent increase for the agency. Read More
On the heels of unanimous recommendations last week by its vaccines advisory committee, the FDA granted Emergency Use Authorization (EUA) on Friday for Moderna’s COVID-19 vaccine for children between six months and 17 years and for Pfizer-BioNTech’s COVID-19 vaccine for children between six months and four years. Read More
The Federal Trade Commission (FTC) has warned drugmakers and pharmacy benefit managers (PBM) that it will be stepping up enforcement of alleged illegal bribes and rebates that hinder patient access to cheaper drugs. Read More
After endeavoring to do so throughout much of the pandemic, the World Trade Organization (WTO) has reached an agreement that allows developing countries to produce their own generic versions of COVID-19 vaccines. Read More