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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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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 several high-profile failures, including BMS’ $1.5B breakup with Agenus, anti-TIGIT therapies are generating cautious optimism.
After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile.
Relay Therapeutics is cutting its workforce to help streamline its research organization as it looks to complete its first large-scale, pivotal clinical trial.
Scaling GLP-1 manufacturing capacity remains a key priority for the pharma industry, to help supply catch up with the insatiable demand for weight loss drugs.
Under the deal announced Friday, the Italian pharma will make an upfront payment of $825 million to Sanofi for global rights to a biologic for the treatment of cold agglutinin disease, with milestone payments of up to $250 million.
The company is lowering its previously issued guidance for 2024 adjusted earnings per share by $0.04 per share to account for acquired in-process research and development expenses incurred for acquisitions and collaborations in the third quarter.
Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy.
While a JAMA study found a decline in mpox antibody responses after vaccination, a University of Oxford expert cautioned that there is still not enough evidence to determine if this decline also leads to waning protections.
Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for treating human immunodeficiency virus in heavily pre-treated adults with multidrug-resistant infections.
The adjusted guidelines will provide drugmakers with more opportunities to engage with the Centers for Medicare and Medicaid Services regarding the initial maximum fair price offers, according to the agency.