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BioWorld - Tuesday, May 19, 2026
Home » Topics » North America » U.S.

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Hair loss drugmaker Veradermics floats upsized $256M US IPO

Feb. 4, 2026
By Marian (YoonJee) Chu
No Comments
Veradermics Inc. raised $256.3 million from an IPO on the New York Stock Exchange Feb. 4. The proceeds will fund three ongoing phase II/III clinical trials of VDPHL-01, its novel oral formulation of Rogaine (minoxidil) to treat pattern hair loss in men and women.
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Amgen headquarters

Amgen thumbs-down on FDA’s ask, Tavneos sales continue

Feb. 4, 2026
By Randy Osborne
No Comments
Amgen Inc.’s head of R&D James Bradner said his firm was “surprised” by the request from the U.S. FDA Jan. 16 to take Tavneos (avacopan) off the market – and the company said no. “We're in discussions with FDA, and we'll answer questions as we talk with them,” he added.
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FTC consent order beefs up PBM reforms in spending bill

Feb. 4, 2026
By Mari Serebrov
No Comments
In a one-two-punch to pharmacy benefit managers (PBMs), the U.S. FTC announced Feb. 4 what it’s calling a “landmark settlement” with the Cigna Group’s Express Scripts Inc. and its affiliates that will require fundamental changes to the company’s business practices.
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FDA updates cybersecurity guidance for medical devices

Feb. 4, 2026
No Comments
The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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Trumprx launch threatened by shutdown, kickback concerns

Feb. 3, 2026
By Mari Serebrov
No Comments
At a recent Cabinet meeting, U.S. Health and Human Services (HHS) Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to a congressional gridlock over a fiscal 2026 appropriations package to keep the department and several others open beyond Jan. 30.
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Cathworks Ffrangio system

Medtronic to acquire Cathworks for $585M

Feb. 3, 2026
By Shani Alexander
No Comments
Medtronic plc is continuing to put its money where its mouth is as it plans to exercise its option to acquire Cathworks Ltd. for up to $585 million. The company said last month it was committed to expanding its pipeline through strategic investments and targeted acquisitions. The move for Cathworks comes on the heels of Medtronic’s $90 million investment in Anteris Technologies Global Corp.
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Ultragenyx fixed on Sanfilippo foe, new data strong

Feb. 3, 2026
By Randy Osborne
No Comments
Another data cut from Ultragenyx Pharmaceutical Inc. regarding UX-111 (rebisufligene etisparvovec), an AAV9 gene therapy for type A Sanfilippo syndrome, continued to brighten the picture for the compound, recently taken under review again by the U.S. FDA.
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Person injecting medicine into abdomen

Pfizer's Metsera GLP-1 hits mark for once-monthly dosing

Feb. 3, 2026
By Karen Carey
No Comments
Nearly three months after winning a contentious bid to buy obesity drugmaker Metsera Inc. for $10 billion, Pfizer Inc. reported its first statistically significant top-line data of the acquired lead, ultra-long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, showing a mean placebo-adjusted weight loss of up to 12.3% at 28 weeks, as well as competitive tolerability.
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Rx manufacturing pilot program launches in US

Feb. 2, 2026
By Mari Serebrov
No Comments
The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S.
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