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.
The U.K. Medicines and Healthcare Products Regulatory Agency opened a second round in its AI airlock program although this round, like the first round, will be limited to four applicants.
The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just behind the 89 approvals recorded in the first five months of 2024.
The June 25-26 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) will be anything but business as usual. In wiping the slate clean just two weeks before the panel was to meet, Health and Human Services Secretary Robert Kennedy made sure of that.
Archeus Technologies Inc. has obtained IND clearance from the FDA for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
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