News
A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
FEATURED STORIES
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
The approval of Eli Lilly’s oral obesity drug officially ignites an intense competition with Novo Nordisk’s oral Wegovy; Gilead Sciences and Neurocrine Biosciences keep the M&A train chugging; Trump hits pharma with his long promised tariffs, and the FDA proposes many changes with 2027 budget.
Some bosses stretch you. Others make work more bearable. Both can earn your loyalty. Only one is building your future. Leadership coach Angela Justice explains how to tell the difference.
As cell and gene therapy developers face rising pressure to produce therapies faster and at lower cost, the industry is leaning on robotics, digital systems and partnerships to bridge the gap between innovation and delivery.
As Daré Biosciences approaches a pivotal year with a key product launch ahead, the company kicked off an open public offering, providing a chance for individuals to get involved for as little as $250.
In the current geopolitical and capital-market uncertainty, biotechs that have not mastered the basics are the ones struggling the most. Here’s how—and why—to get the details right.
The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcellx and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.
Humira will be available on TrumpRx at an 86% discount, according to media reports, as part of AbbVie’s deal with the White House to avoid tariffs. The news comes less than a week after the president announced up to 100% levies on pharma products.
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.”
Sales of Amgen’s thyroid eye disease drug Tepezza have slowed, dipping 1% to $457 million in the fourth quarter of 2025.