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…
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…
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…
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. Source: Drug Industry Daily
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…
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…
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…
Acadia is having another go at Nuplazid (pimavanserin), hoping to convince the FDA’s Psychopharmacologic Drugs Advisory Committee that the antipsychotic should win a new indication as a treatment for dementia-related…
Acadia is having another go at Nuplazid (pimavanserin), hoping to convince the FDA’s Psychopharmacologic Drugs Advisory Committee that the antipsychotic should win a new indication as a treatment for dementia-related…
Roche is finally throwing in the towel on crenezumab, the antiamyloid antibody researchers hoped might prevent the disease in a group of South American families genetically destined to develop it…