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.

Two U.S. Medicare administrative contractors (MACs) have removed CPT code 6468 from their group 1 CPT codes, a move that may cut rates for implant of Inspire Medical Inc.'s flagship product, the Inspire hypoglossal nerve stimulator for treatment of obstructive sleep apnea.

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.

The U.S. FDA approved 18 drugs in November, down from 20 in October, bringing the total number of clearances to 199 through the first 11 months of the year. The number is about 5% lower than the 209 approvals recorded over the same period in 2024 but more than every prior year.

Focused on antibody-drug conjugates (ADCs), Neok Bio Inc. made a moderate splash by emerging from stealth mode in November with a $75 million series A financing led by Abl Bio Inc. – and one aspect of its drug development is gaining momentum in various other quarters, including big pharma.

Biomarin Pharmaceutical Inc. followed up its May takeover of Inozyme Pharma Inc. with a much larger agreement to acquire Amicus Therapeutics Inc. for $14.50 per share in an all-cash transaction, tipping the equity-value scale about $4.8 billion.

The American College of Cardiology (ACC) and the American Heart Association (AHA) issued new scientific statements advocating use of quantified coronary plaque analyses in management of patients with coronary artery disease. The statements move plaque analysis based on AI-powered coronary computed tomography angiography to a defined clinical consideration in cardiac management, up from "an emerging technology."

The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.

Eli Lilly and Co. took another step toward adding a way for patients to hang onto their weight loss when the firm disclosed positive top-line data from the phase III Attain-Maintain trial with orforglipron, a once-daily oral small molecule GLP-1 receptor agonist. Indianapolis-based Lilly said that at one year orforglipron met the primary and all key secondary endpoints vs. placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity, using the efficacy estimand and modified treatment-regimen estimand.