The U.S. FDA said June 25 it has required updates to the prescribing labels of COVID-19 mRNA vaccines Comirnaty and Spikevax to include new safety information on the risks of myocarditis and pericarditis.
Although the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) was scheduled to vote June 25 on recommendations for maternal and pediatric respiratory syncytial virus vaccines, it adjourned by pushing that vote to the second day of the meeting. But before leaving for the day, it got an earful of comments from pediatricians, nurses and even a retired FDA scientist urging the CDC to reinstate the 17 committee members Health and Human Services Secretary Robert Kennedy dismissed two weeks earlier and replaced with eight new members.
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
Barely a day before the eight new members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are supposed to hold their first meeting, Sen. Bill Cassidy, R-La., called for the June 25 meeting to be postponed.
“I expressed deep concerns with your nomination, Secretary Kennedy, and somehow, unfortunately, you have exceeded my expectations in the worst possible ways,” U.S. Rep. Frank Pallone, D-N.J., told Health and Human Services (HHS) Secretary Robert Kennedy during a June 24 House subcommittee hearing.
The Medicare Payment Advisory Commission advised Congress that inflation is taking a bite out of physician pay and Medicare payments may have to increase in order to preserve patient access to care.
Deepecho Inc. received the U.S. FDA’s nod for its AI-based platform that assesses fetal biometry and amniotic fluid volume to improve the efficiency and precision of fetal ultrasound diagnostics.
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