An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is meeting on May 19 to discuss whether to recommend COVID-19 vaccine booster shots for children ages 5 to 11, a group that is just 29% vaccinated so far.
Current COVID-19 booster shots have a problem: they last only about four months and appear to have limited efficacy in a vaccinated population. Clearly, a more durable, more efficacious vaccine is needed, but what should it be? The scientific community has not reached a consensus, according to BioSpace.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Six members of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted not to approve Amylyx Pharmaceuticals’ new drug application (NDA) for the company’s amyotrophic lateral sclerosis (ALS) candidate AMX0035, while four voted yes.
The U.S. drug regulator said on March 21 a panel of independent advisers will meet on April 6 to discuss considerations for use of COVID-19 vaccine booster doses.
On the day the public and members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee were going to get a look at Pfizer and BioNTech’s COVID-19 vaccine data for children under 5 years old, the companies pulled the Emergency Use Authorization (EUA) submission.
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.
Reata Pharmaceuticals Inc. announced the outcome of the U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting on bardoxolone methyl for the treatment of patients with chronic kidney disease caused by Alport syndrome.
Shares of Reata Pharmaceuticals were down nearly 40 percent the morning of December 6 after briefing documents released by the U.S. Food and Drug Administration revealed an unflattering opinion of the company’s experimental drug for Alport syndrome, bardoxolone.