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FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
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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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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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Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.
One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.
Pfizer’s sudden market withdrawal of sickle cell therapy Oxbryta, which some analysts predicted would reach $750 million in sales by the end of the decade, has left patients and healthcare providers with few options, while investors question the pharma giant’s dealmaking prowess.
Already approved in six indications, Sanofi and Regeneron can now add chronic obstructive pulmonary disease to the list for their blockbuster injection.
BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors.
Sen. Bernie Sanders’ aggressive targeting of Danish drugmaker Novo Nordisk’s Ozempic and Wegovy pricing, and not Eli Lilly’s rival drugs, is not fair.
The FDA’s Oncology Drugs Advisory Committee voted near-unanimously that the benefits of PD-1 inhibitors like Keytruda and Opdivo in PD-L1 low patients do not outweigh the risks.
Results from TEMPO-1, which showed that tavapadon significantly improved motor symptoms in patients with Parkinson’s disease, will help AbbVie as it builds a regulatory case for the D1/D5 dopamine receptor agonist.
Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate.
In the Phase III REGENCY study, Gazyva elicited superior complete renal response rates in patients with lupus nephritis versus placebo, positioning Roche’s therapeutic antibody for expansion into the indication.