News Related to eGFR

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FDA Approves Monthly Dosing for Johnson & Johnson's Rybrevant Faspro in NSCLC

Mar 23, 2026

The FDA has approved a monthly subcutaneous dosing schedule for Johnson & Johnson's Rybrevant Faspro for EGFR-mutated NSCLC, based on PALOMA-2 trial data showing 82-87% response rates. The approval follows the drug's initial biweekly dosing approval in December 2025 and offers reduced administration time and reactions compared to intravenous delivery.

Dizal's Zegfrovy Meets Phase III NSCLC Endpoint as Other Trials Fail

Mar 23, 2026

Dizal's Phase III trial of Zegfrovy for first-line NSCLC with EGFR exon20ins met its primary endpoint, showing improved progression-free survival. Meanwhile, Immutep halted its Phase III eftilagimod alfa trial, and AstraZeneca's LATIFY trial of ceralasertib plus Imfinzi failed to meet its overall survival endpoint.

Finerenone Shows Kidney Benefit in Non-Diabetic CKD in Phase III FIND-CKD Trial

Mar 19, 2026

Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.

FDA Accepts Imlifidase BLA for Kidney Transplant Desensitization

Mar 06, 2026

The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.