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BioWorld - Sunday, January 11, 2026
Home » Topics » North America » U.S.

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The year in review

Vaccine policy and the terrible, horrible, no good, very bad year

Dec. 23, 2025
By Anette Breindl
No Comments
Driven by a deeply antiscientific political agenda, the current U.S. government is not just sabotaging some of the most groundbreaking technology that has been developed in the past decades. It is also destroying the country’s past successes, such as measles elimination and the reduction of hepatitis B infections in infants to near zero.
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Handshake with tech background

Harbour Biomed closes busy year with $1B+ BMS deal

Dec. 23, 2025
By Lee Landenberger
No Comments
Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. (BMS) to develop multispecific antibodies. Harbour is getting about $90 million up front, but milestones could eventually top $1 billion.
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Pills spilling out of bottle onto money

White House continues to stomp down on US drug prices – for some

Dec. 22, 2025
By Mari Serebrov
No Comments
Then there were three. With the administration’s Dec. 19 announcement of most-favored-nation (MFN) pricing deals with nine more biopharmas, only three of the 17 companies on the receiving end of U.S. President Donald Trump’s July 31 MFN ultimatum have yet to finalize terms with the White House – Abbvie Inc., Johnson & Johnson (J&J) and Regeneron Pharmaceuticals Inc.
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Abstract blue human heart with red cardio pulse line and red circle

FDA says yes to Cytokinetics’ aficamten, now Myqorzo, in oHCM

Dec. 22, 2025
By Randy Osborne
No Comments
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.
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Abbott Labs Volt

A pleasant shock: Abbott’s Volt PFA system snags early FDA approval

Dec. 22, 2025
By Annette Boyle
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.
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Medicare puzzle

MAC attack on CPT code for hypoglossal nerve stimulation dings Inspire

Dec. 22, 2025
By Mark McCarty
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.
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Rubber duck dressed up as a doctor
The year in review

In 2025, science’s biggest story was political

Dec. 22, 2025
By Anette Breindl
No Comments
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.
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FDA Approved stamp with pills
Biopharma regulatory actions and approvals October 2025

Rare diseases drive November’s US drug approvals

Dec. 19, 2025
By Amanda Lanier
No Comments
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.
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Antibody-drug conjugate

B7-H3 money tree? Target catching on in ADCs

Dec. 19, 2025
By Randy Osborne
No Comments
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.
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Rare disease illustration

Rare earth: Biomarin to use global reach post-$4.8B Amicus buy

Dec. 19, 2025
By Randy Osborne
No Comments
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.
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