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Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
FEATURED STORIES
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
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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
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.
At the World Vaccine Congress this week, Novavax presented data suggesting that its protein nanoparticle booster generated immune responses that could protect against severe infection.
Phase IIa data showed AI Therapeutics’ ALS candidate increased expression of a target engagement biomarker and led to a 73% reduction in a toxic protein aggregate.
Farallon Capital Management is waging a proxy battle with Exelixis over R&D spending. The hedge fund issued a letter to the company’s board of directors on Wednesday.
NLRB General Counsel Jennifer Abruzzo issued a memo to all field offices clarifying the board’s recent ruling in a case regarding severance agreements.
Phase III data for Pfizer’s respiratory syncytial virus vaccine candidate showed high levels of protection for older adults and infants.
AstraZeneca’s Imfinzi and Lynparza met primary endpoint markers in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to data released Wednesday.
Proxygen added Merck to its partner roster on Wednesday, garnering an undisclosed upfront payment plus a potential $2.55 billion in milestones.
The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.