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Korsana’s lead program uses a next-generation shuttling technology to improve delivery into the brain and lower the incidence of amyloid-related imaging abnormalities.
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Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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After receiving a complete response letter for its pyruvate dehydrogenase complex deficiency candidate, Saol Therapeutics anticipates it will need “several years” and “significant financial resources” to address the FDA’s concerns.
Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.
Novartis has been investing heavily in its cardiovascular pipeline this year, forging partnerships with Flagship startup ProFound Therapeutics and China’s Argo Biopharmaceutical, among others.
Regeneron’s antibody duos significantly lowered eye itching and redness, as well as pin prick reactivity, in people with cat and birch allergies. Still, BMO Capital Markets expressed uncertainty about the assets’ “commercial potential in a highly generic market.”
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.”
The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.