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Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The U.S. Supreme Court recently declared an end to race-conscious admission programs into colleges and universities, which could have a trickle-down effect on hiring.
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
CSL’s AEGIS-II trial and cell and gene therapy expansion highlight the significant global expansion within the company over the past five years.
The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.
Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.
Amid high rates of U.S. obesity, a bipartisan bill has been reintroduced in the Senate and House of Representatives with backing from Eli Lilly, Novo Nordisk and Boehringer Ingelheim.
The company’s sales guidance for 2023 has been raised to $98.8 billion to $99.8 billion, driven by cancer drugs and medical devices. J&J’s stock rose about 5% in early trading Thursday.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.