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The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
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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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Araris Biotech AG secured $24 million in financing to advance the development of its proprietary antibody-drug conjugate (ADC)-linker technology and drive its own ADC candidates into the clinic.
miRecule inked Tuesday a research partnership and licensing deal with Sanofi worth $30 million that will advance a best-in-class antibody-RNA conjugate to treat FSHD.
Ginkgo Bioworks opened its wallet Tuesday and snapped up Circularis and Altar to strengthen its cell and gene therapy programs and bolster its manufacturing capabilities.
Bristol Myers Squibb entered two separate research collaboration and licensing deals, one with San Francisco-based SyntheX and the second with London’s Autolus Therapeutics.
Early data from the Phase III TALAPRO-2 study showed Talzenna, Pfizer’s oral PARP inhibitor, met its primary endpoint in metastatic castration-resistant prostate cancer patients.
KalVista Pharmaceuticals announced Tuesday that life-threatening safety concerns prompted it to shut down a mid-stage clinical trial for hereditary angioedema.
With ambitions to enter the clinic in the first half of 2023, Keir Loiacono, esq., aims to double down on BlueSphere’s strengths rather than make any major course corrections.
Synlogic, Senti Biosciences and Novome are pioneering the field of synthetic biotics, which is so new there are only a handful of scientific articles using either that term or ‘engineered living therapeutics.
Scandion Oncology, Edesa, Clovis, Lexicon and Cytokinetics share a string of positive news from their clinical trials on heart failure, cancer, COVID-19 and ARDS.
Incyte Corporation will acquire privately-held Villaris and AmplifyBio will acquire PACT Pharma, while Estrella will gain a spot on the Nasdaq Exchange.