Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism Experts call the move “extremely premature”

Trump claims that autism is caused by Tylenol use during pregnancy, advises to “fight like hell not to take it”

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.

September 26, 2025

Vol.51 No.35

By Claire Marie Porter

Drugs & Targets

FDA approves Keytruda Qlex injection for subcutaneous use in 38 tumor indications

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.

FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

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.

September 26, 2025

Vol.51 No.35

Cancer Policy

FDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz

FDA has begun to crack down on direct-to-consumer prescription drug advertising.

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

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.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA approves Bosaya and Aukelso, denosumab biosimilars, for osteoporosis

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.

September 19, 2025

Vol.51 No.34

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism

Experts call the move “extremely premature”

YOU MAY BE INTERESTED IN

Trump claims that autism is caused by Tylenol use during pregnancy, advises to “fight like hell not to take it”

FDA approves Keytruda Qlex injection for subcutaneous use in 38 tumor indications

FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

FDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA approves Bosaya and Aukelso, denosumab biosimilars, for osteoporosis

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