The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The inevitable legal challenge succeeded wildly in a decision rendered in district court in March 2025, marking one of the rare instances in which the courts thwarted FDA rulemaking and thus is easily the regulatory story of the year for 2025. Attempts to regulate AI in the U.S. and Europe also dominated the regulatory landscape.

Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.

Enveda has obtained IND clearance from the FDA and initiated a phase I trial of ENV-6946, a first-in-class oral small molecule for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.

Needle-phobic obesity patients got their first workaround with the U.S. FDA clearance of Novo Nordisk A/S’ once-daily GLP-1 Wegovy (semaglutide) pill, the first of its kind.

Edwards Lifesciences Corp. received U.S. FDA approval for its Sapien M3 mitral valve replacement system, making it the first transcatheter therapy utilizing a transseptal approach to be indicated for treatment of mitral regurgitation (MR). The Sapien M3 transcatheter mitral valve replacement system is indicated for the treatment of patients with symptomatic moderate-to-severe or severe MR or symptomatic mitral valve dysfunction who are deemed unsuitable for surgery or TEER by a multidisciplinary heart team.

Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5 interstitial lung disease events. The company did not say how many deaths there had been.

Cytokinetics Inc. scored U.S. FDA marketing clearance Dec. 19 for Myqorzo (aficamten) 5-mg, 10-mg, 15-mg, and 20-mg tablets to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Shares of the South San Francisco-based firm rose 4.6%, or $2.88, on Dec. 22 to close at $65.60.

Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation.

Enveda has obtained IND clearance from the FDA and commenced dosing in a phase I study of ENV-308, a once-daily oral therapy designed for chronic weight management.

In 2025, science saw its breakthroughs, which BioWorld will be covering as part of our end-of-the-year wrap-up. But the biggest science story of 2025 is not about any scientific advance. It is the politicized destruction of U.S. science, and the dismantling of a scientific ecosystem that has been the envy of the world since it emerged after Germany destroyed its own pre-eminence in the 1930s.