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The FDA has revised the Risk and Evaluation and Mitigation Strategy (REMS) for the generic anti-psychotic drug clozapine in an effort to improve patient monitoring for the rare blood disorder neutropenia. Read More
Remi Barbier, CEO and founder of Cassava Sciences, has gone on the defensive after independent scientists called into question the positive preliminary results of the company’s small Alzheimer’s drug study. Read More
The FDA has issued a second noncompliance letter to Georgia-based biopharmaceutical firm Accuitis for failing to submit clinical trial results to the National Institutes of Health’s ClinicalTrials.gov data bank. Read More
The ALS community is frustrated with comments made by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Review (CDER), during a congressional hearing last week focused on the slow pace of drug approvals for neuro drugs. Read More
The House voted yesterday 219 to 208 to pass a “minibus” fiscal 2022 spending package that includes about $257 million in increased nonuser-fee funding for the FDA and a total fiscal 2022 budget including user fees of $6.3 billion for the agency. Read More
The FDA has revised its Emergency Use Authorization (EUA) for Eli Lilly’s and Incyte’s COVID-19 treatment Olumiant (baricitinib) to authorize giving the drug alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years or older requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Read More
Seven members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee are knocking heads with FDA officials over Aduhelm with sparring editorials published in the New England Journal of Medicine. Read More
The trial has been postponed until Aug. 4 to give the plaintiffs time to decide whether to accept the settlement in place of the $2.4 billion they were expected to demand. Read More
Despite calls to hurry the process, FDA reviews of COVID-19 vaccine Biologics License Applications (BLAs) are proceeding ahead of schedule, with full approvals expected this fall, says regulatory expert Melissa Tice from George Washington University (GWU). Read More
Humana has filed a racketeering and fraud suit against Regeneron Pharmaceuticals, alleging that the company engaged in a kickback scheme so it could inflate the price of its macular degeneration drug Eylea. Read More