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Drug Development News

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Roche pours $750M into Oregon manufacturing plant as obesity push expands

After committing $2 billion to a new North Carolina facility to boost capacity for its next-gen obesity candidates, Roche's Genentech is putting down more cash to expand a device fill-finish site in Oregon.

Scribe’s early-stage IPO standout defies biotech’s derisking trend

Scribe Therapeutics’ one-time epigenetic treatment is designed to slash the adherence burden of chronic cholesterol-lowering therapies while sidestepping the irreversibility of gene editing.

Regeneron wins FDA approval to challenge Ipsen for rare bone disease market

Regeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos.

Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision

The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently reviewing for a second time. A decision is expected by mid-September.

Merck’s Moderna-partnered vaccine success clears view of post-Keytruda future

Investors had been pessimistic about the probability of success for the personalized cancer vaccine intismeran autogene, so the Phase 3 win was a welcome surprise.

Rewriting the rules of CMV prevention

In this episode of Denatured, you’ll hear from Ian McGowan, Chief Medical Officer at Synklino and James Hunter, associate professor of transplantation at Oxford University. We explore transplantation and antiviral innovation and why CMV remains one of the most persistent and consequential challenges facing transplant patients today.

Why pediatric rare oncology outperforms in a volatile biotech market

Real progress happens where unmet medical need is greatest and patient impact can be clearly measured. Pediatric rare cancers exemplify these criteria and have therefore generated continued investment, even in a capital-constrained environment.

Moderna stock nearly doubles as Merck-partnered mRNA cancer vaccine meets Phase 3 goal

Melanoma was slower to recur in patients receiving Merck and Moderna's mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.

Enveda’s exercise-simulating obesity tablet clears early clinical test

Touting an “exceptional” gastrointestinal safety profile for its oral obesity drug candidate in a study of healthy volunteers, Enveda plans to test the asset in people stopping GLP-1 treatment.

2026 IPO stock tracker: How newly public biotechs are performing

BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.