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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.
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA
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.
THE LATEST
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
Gilead underscored its faith in the combo therapy and pledged to work with regulators to resolve the hold, which has paused five clinical trials. Gilead also stressed that the hold does not impact any other assets in its HIV pipeline.
Robert F. Kennedy Jr.’s removal of all remaining members of the CDC’s Advisory Committee on Immunization Practices raises questions about the upcoming meeting later this month. Analysts fear the committee could be more sympathetic to the HHS Secretary’s anti-vax viewpoints.
As of March 31, Recursion Pharmaceuticals had a cash position of $509 million. Following Tuesday’s layoffs, the biotech expects its runway to last into the fourth quarter of 2027.
IPO
Odyssey filed for an IPO in January but never revealed a fundraising target.
RSV
Merck’s Enflonsia will go up against Sanofi and AstraZeneca’s Beyfortus, which the partners plan to ship out early in the third quarter.
The reinstatement of the generic drug policy office is the latest reversal of course for Robert F. Kennedy Jr.'s HHS, which also recently rehired FDA staff responsible for making travel arrangements and those involved in user fee program negotiations.
Two weeks of upheaval at the CDC culminated Monday in the complete reconstitution of the CDC’s Advisory Committee on Immunization Practices as HHS Secretary Robert F. Kennedy Jr. pens op-ed criticizing “conflicts of interest” he says exist on the current committee.
Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026.
The loss of special government employee status for four members of the CDC’s Advisory Committee on Immunization Practices follows the resignation of ACIP co-lead Lakshmi Panagiotakopoulos, who left in protest of a controversial change in COVID-19 recommendations for healthy children and pregnant women.