News
After a sluggish 2025, biotech IPOs have roared back to life. Fueled by resilient stock performances and improving market sentiment, the total number of public debuts so far this year has already eclipsed 2025’s total.
FEATURED STORIES
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
While decentralized trials are expediting innovation and promoting diversity, challenges remain, including complex stakeholder ecosystems, skills gaps and regulation.
The company said it’s preparing to file a New Drug Application with the FDA on the strength of late-stage study data for its investigational RNA-targeted donidalorsen in patients with hereditary angioedema.
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
In a Phase I/II trial, an 11-year-old boy gradually regained hearing—eventually reaching normal range for some frequencies at 30 days—following treatment with Eli Lilly’s dual adeno-associated viral vector-delivered gene therapy.
Drug discovery requires complex and multi-faceted decisions to justify billion-dollar investments that will take years to realize.
This week, Lori, Greg and Tyler discuss the first surge of IPO activity this year plus gene therapy pricing,
The Danish pharma has signed a collaboration and license agreement with Swiss biotech EraCal Therapeutics to access a novel candidate for controlling appetite and body weight.
After showing some unfavorable results for its data, AC Immune on Monday announced it will be getting back its Alzheimer’s disease candidates from Roche’s Genentech.
Johnson & Johnson exceeded fourth-quarter earnings estimates, reporting nearly $21.4 billion in revenue, as its pharma business faces a patent cliff with Stelara competition entering the market.