FDA has initiated the approval of leucovorin calcium tablets, rushing them to market as part of a push from the Trump administration to identify potential treatments for autism spectrum disorder.
In a press conference on Sept. 22, President Donald Trump, flanked by NIH Director Jay Bhattacharya, FDA Commissioner Marty Makary, HHS Secretary Robert Kennedy Jr., and CMS Administrator Mehmet Oz, touted that Tylenol use while pregnant is “probably” the cause of autism.
FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Sept. 19 for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.
AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the U.S. FDA for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
FDA has begun to crack down on direct-to-consumer prescription drug advertising.
FDA approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
FDA approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) injections, biosimilars of Prolia and Xgeva respectively, for the treatment of osteoporosis. In addition, FDA granted provisional interchangeability designation for both Bosaya and Aukelso.
FDA approved selumetinib (Koselugo) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.
FDA and Telix have reached an agreement regarding resubmission of its New Drug Application for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.
Vinay Prasad has regained his role as FDA’s chief medical and scientific officer, according to an update on the agency’s website.
