The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the first oral GLP-1 for treating chronic weight management. So far, however, it has been injectables leading the way to approval.

Mammoth Biosciences Inc. has nominated its first clinical development candidate – MB-111 – a potential one-time treatment for patients with very high triglycerides, including familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia. IND-enabling studies are on track to begin this year.

With strong one-year results from the PULSAR trial, Kardium Inc. could soon be jockeying for third place in the race for pulsed field ablation market share. Boston Scientific Corp. clearly won the roses, with Medtronic plc solidly positioned to place, but the show spot – previously called as a battle between Johnson & Johnson and Abbott Laboratories – could go to this Canadian dark horse.

Wall Street immediately set to weighing the long-term import of Cytokinetics Inc.’s regulatory delay with aficamten, but the short-term impact was evident, as shares (NASDAQ:CYTK) dipped to close May 2 at $37.35, a loss of $5.57 or 13%.

In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis.

Presentations at Heart Rhythm 2025 for Field Medical Inc. and Adagio Medical Holdings Inc. demonstrated success in two very different types of ablation for ventricular tachycardia, potentially offering new options for a harder-to-treat type of arrhythmia.

Pulsed field ablation dominated discussions and scientific sessions at Heart Rhythm 2025 in San Diego with researchers and manufacturers touting new applications in persistent atrial fibrillation, atrial flutter and addressing specific challenges for existing systems.

Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.

Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.