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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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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.
With over 20% of people born between 1997 and 2003 identifying as a sexual and gender minority, moderated panels at SCOPE 2024 discuss the need to engage this community in clinical trials.
Johnson & Johnson’s anti-BCMA antibody can now be dosed once every two weeks in relapsed or refractory multiple myeloma patients who have achieved and maintained complete response for at least six months.
A federal judge in New Jersey has agreed to hear legal challenges from BMS, J&J, Novartis and Novo Nordisk to the Inflation Reduction Act’s Drug Price Negotiation Program during the same March 7 hearing.