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.

After being unanimously passed by the U.S. House Dec. 1, the bipartisan Mikaela Naylon Give Kids a Chance Act seemed to be headed for sure passage in the Senate before it adjourned late last week.

Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration (NMPA) with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT).

Six individuals, including an investment banker, face multiple U.S. charges stemming from an alleged $41 million insider-trading scheme, plus stock manipulation schemes involving biopharma companies. The charges are related to three overlapping securities fraud schemes that occurred between June 2020 and February 2024.

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.

Reviva Pharmaceuticals Holdings Inc. may be headed back to the clinic for another phase III study of brilaroxazine in treating schizophrenia. With a successful series of early and mid-stage studies behind the treatment, the U.S. FDA recommended a second study for the serotonin-dopamine and neuroinflammatory signaling modulator after a pre-NDA meeting in order to net more efficacy results and expand the safety dataset.

The EU’s Medical Device Coordination Group (MDCG) posted two guidances in the waning weeks of 2025, one of which deals with postmarket surveillance for both devices and diagnostics. Another guidance deals with breakthrough devices (BtX) and diagnostics, a question that is not well described in either of the current EU regulatory frameworks.

Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.

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.

The long-running dispute over rebates on sales of drugs that the pharma industry must pay to the U.K. government took a turn for the worse at the start of 2025, when it transpired that the rate would be going up from 15.3% to 22.9%. The row continued for most of the rest of the year before a truce of sorts was called in December.