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The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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.
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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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With the departure of AbbVie and AstraZeneca from the trade group, Pharmaceutical Research and Manufacturers of America has named new members to its leadership including Gilead Sciences chief Daniel O’Day.
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.
On the heels of Takeda’s $300 million licensing deal for rusfertide, Protagonist Therapeutics’ peptide mimetic lowered hematocrit levels in patients with polycythemia vera, a type of blood cancer.
Danish biotech Bavarian Nordic announced Wednesday it is discontinuing its immuno-oncology program and will focus its R&D efforts on infectious diseases.
If you’re a sales professional looking for a new position, here are some companies currently looking to fill sales roles on BioSpace.
Artificial intelligence and a flood of data in the pharmaceutical industry will likely change some of the current functions of its data scientists, experts say, but the ability to learn and adapt to new technologies will remain key in this role.
President and COO Robert Michael will take over Richard Gonzalez’s CEO duties, AbbVie announced Tuesday. Gonzalez will become executive chairman of the board of directors.
The litigation alleges the regulator allowed its competitor Liquidia to skirt FDA precedents by amending an already pending NDA to add a PH-ILD indication instead of filing a new application.
After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise.
ViiV Healthcare and GSK’s Cabenuva in a Phase III study showed superior efficacy versus daily oral antiretroviral treatment in HIV patients with a history of difficulties in taking daily pills.