Also known as: F.D.A., FDA, Food and Drug Administration, The U.S. Food and Drug Administration, U.S. F.D.A., U.S. FDA, US FDA, USFDA, U.S. Food & Drug Administration, US Food & Drug Administration
Japan's MHLW granted Orphan Drug Designation to three investigational therapies: gildeuretinol for Stargardt disease, QRX003 for Netherton Syndrome, and E2086 for narcolepsy, each offering potential 10-year market exclusivity.
Everything Sprouts LLC recalled alfalfa sprouts after 55 E. coli and Salmonella illnesses in 15 states. Four people were hospitalized; no deaths were reported. Consumers should discard affected products.
Alumis reported that 54% of psoriasis patients achieved complete skin clearance (PASI 100) at 48 weeks in the ONWARD3 study, with 75% achieving PASI 90. The company plans to submit an NDA for envudeucitinib in Q4 2026.
AbbVie will present new lung cancer data at WCLC 2026, including Phase 1b results for ABBV-1480 showing high response rates in NSCLC and safety updates for ABBV-706 in SCLC. The company also reported progress in dermatology, obesity, and Crohn's disease programs.
New research shows that many people with disease-causing gene mutations never develop illness, challenging traditional assumptions. Studies of 'modifier genes' and genetic outliers are revealing how some individuals stay healthy, potentially leading to new treatments for genetic diseases.
IceCure Medical's ProSense cryoablation system gains IRB approval for the ChoICE post-marketing study in low-risk breast cancer, with patient enrollment expected soon. Additionally, Thomas Hospital in Alabama becomes the first facility in the state to install ProSense, with procedures starting this month.
The FDA has declined approval for Disc Medicine's rare disease therapy, which was previously associated with the commissioner's voucher program. The rejection marks a setback for the company's efforts to bring the treatment to market.
Longeveron appoints Nirav Jhaveri as CFO, succeeding Marie Washburn. The company anticipates Phase 2b trial results for laromestrocel in HLHS in September, with FDA guidance that a successful trial would be pivotal for BLA filing.
The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
Merck and Moderna's personalized mRNA cancer vaccine combined with Keytruda significantly reduced melanoma recurrence risk in a Phase 3 trial. The FDA has not yet approved the vaccine, with potential availability expected by early 2027.
