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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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Amgen opened a new research and development site in San Francisco Bay, while Enzo Biochem opened a 100,000 square foot laboratory and research facility in New York
Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in LBCL.
BioMarin Pharmaceuticals announced Friday it was shedding around 4% of its global workforce, or around 120 jobs, in an effort to improve its operational efficiency.
Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.
Surrozen announced Thursday it has partnered with Boehringer Ingelheim to research and develop a therapeutic for the treatment of retinal diseases.
Movers & Shakers: New C-Suites for Assembly Biosciences, Urica Therapeutics, BlueSphere Bio and More
Life sciences and biopharma companies added new CEOs, CMOs and CSOs to guide their companies into the future and oversee developmental programs.
Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity.
After an earlier stumble this year with its investigational major depressive disorder therapeutic, Eliem Therapeutics appears to be back on track with a planned Phase II study of ETX-155.
TauRx announced preliminary results from the Phase III study, showing HMTM, its potent inhibitor of tau aggregates, could slow Alzheimer’s disease progression or cognitive decline.
Red Tree Venture Capital closed a $272 million inaugural fund that will be used to support the development of therapeutics addressing unmet needs in oncology, neurology and immunology.