The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.
The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorldfor the period, after 2024’s high of 159.
Renewing hopes of restoring the rare pediatric disease priority review voucher (RPD PRV) program that expired at the end of 2024, the House Energy and Commerce Committee voted 47-0 Sept. 17 to advance the Give Kids a Chance Act of 2025 (H.R. 1262), one of six pieces of legislation slated to move to the full U.S. House for consideration.
The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking.
Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.
Despite some expectations that the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) would dramatically change the childhood vaccine schedule for hepatitis B, the committee is poised to vote Sept. 19 on a much smaller change that would move the current birth dose to 1 month for infants born to mothers who test negative for hepatitis B.
The American Academy of Pediatrics (AAP) and a few other medical professional groups were no-shows at the Sept. 18 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices. The absence of the liaison groups was noted, especially that of the AAP. In opening the two-day meeting, ACIP Chair Martin Kulldorff said he lamented that the AAP has ended its association with the committee.
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
With positive phase III results in hand, Roivant Sciences Ltd. and Priovant Therapeutics Inc. anticipate an NDA filing in the first half of 2026, seeking approval for brepocitinib, a dual inhibitor of tyrosine kinase 2 and JAK1, in dermatomyositis, a rare autoimmune disease with limited treatment options.
The Sept. 17 U.S. Senate Health, Education, Labor and Pensions Committee hearing on the CDC is throwing even more shade on the upcoming meeting of the agency’s reconstituted Advisory Committee for Immunization Practices (ACIP), which is expected to recommend changes to the childhood vaccine schedule.
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