Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill.

A U.S. FDA complete response letter (CRL) citing manufacturing concerns has stepped into the way of a rare genetic disorder treatment. Fortress Biotech Inc. and its subsidiary, Cyprium Therapeutics Inc., said the letter in response to the NDA for CUTX-101, an injectable formulation of copper histidinate, noted cGMP deficiencies at the facility where the Menkes disease treatment is manufactured.

Patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment now have a new oral treatment option, with the U.S. FDA’s approval of Novartis AG’s Rhapsido (remibrutinib), a Bruton’s tyrosine kinase inhibitor administered by pill twice daily.

The U.S. FDA’s early alert program has communicated a number of potential device malfunction episodes since its inception in late 2024, but the agency announced that the program is now moving out of the pilot phase to include all device types as of Sept. 29.

Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills.

Simcere Zaiming Pharmaceutical Co. Ltd. has obtained IND clearance by the FDA for SIM-0609, a CDH17-targeting antibody-drug conjugate (ADC) for the treatment of advanced solid tumors. An IND was also approved in China earlier this month.

The U.S. FDA released a trio of draft guidances to help sponsors in developing and monitoring cell and gene therapies, as well as other regenerative medicine therapies.

Eli Lilly and Co.’s oral selective estrogen receptor degrader (SERD) imlunestrant has been approved by the U.S. FDA for treating late-stage breast cancer patients. Branded Inluriyo, the second-line treatment is for treating adults with estrogen receptor-positive, human epidermal growth factor receptor-2-negative estrogen receptor 1-mutant advanced or metastatic breast cancer.

Crinetics Pharmaceuticals Inc.’s green light under priority review from the U.S. FDA for Palsonify (paltusotine) in first-line acromegaly sets up a not-uncommon David vs. Goliath-type scenario in the indication caused by excessive growth hormone made by the pituitary gland.