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Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from related indications or animal models.
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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.
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.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
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Read our takes on the biggest stories happening in the industry.
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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In the second episode of our series on women’s health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories.
Takeda Oncology US Head of Sales, Annette Montandon, discusses how embodying a patient-first approach is key to the success of colorectal cancer drug FRUZAQLA®.
Here’s how to assess whether to develop a new therapy by building a proprietary platform, acquiring another company or asset or partnering with an established entity.
Xaira Therapeutics emerged from stealth on Tuesday with plans to tap the biological equivalent of artificial intelligence image generation tools designed to create molecules that hit hard-to-drug targets.
While the San Diego-based biotech awaits a Phase IIa data readout for its lead lung disease candidate, Endeavor BioMedicines’ next-generation HER3-targeted antibody-drug conjugate will start a Phase I/II trial later this year.
A report from the Kaiser Family Foundation estimates that the FDA’s recent approval of Novo Nordisk’s Wegovy to reduce the risk of heart attack and stroke in people with cardiovascular disease will open Medicare coverage to one in four beneficiaries with obesity.
Biogen on Wednesday exceeded analyst profit estimates for the first quarter of 2024 as the biotech’s cost-cutting measures took hold and sales of its Alzheimer’s disease therapy Leqembi started to pick up.
The Celularity CEO and founder tells BioSpace he believes that placenta-derived cells are the future of stem cell therapies to fight autoimmune disease, cancer, even aging.
Despite being hit with a continuing decline in COVID-19 sales and a strong Swiss franc, Roche on Wednesday reported first-quarter sales were up 2% at constant exchange rates.
An undisclosed once-daily oral dose of Neurocrine Biosciences’ Takeda-partnered investigational drug significantly reduced symptom severity in adults with major depressive disorder.