News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Bristol Myers Squibb’s moneymaker cancer drug Revlimid has finally found a competitor in Israel-based Teva Pharmaceuticals’ generic version, lenalidomide.
Sanofi will more than $1 billion to build out its mRNA facilities and programs over the next several years. The site is expected to become operational in 2025.
Currently, women with breast and ovarian cancers have limited treatment options. Anixa Biosciences, ImmunoGen and IMV are working to change that.
Creyon Bio, a drug development company, has launched with more than $40 million in seed and Series A financing led by DCVC Bio and Lux Capital.
The trial’s primary endpoint was to assess endometrial health, with additional goals of evaluating the safety and tolerability of the drug.
According to a BIO report, less than a third of executive team members are women. BioSpace spoke with three influential women in biopharma to get their advice on breaking the executive barrier.
Agenus and Targovax partner on a KRAS cancer vaccine, Elixirgen and Taisho target aging and Tonix and Mass General team up again to fight kidney transplant rejection.
Andrey Tolmachov issued a letter to the global drug discovery and scientific community, underscoring the importance of condemnation and action against Russian invasion.
Gilead Sciences posted some good news: a late-stage study of its antibody-drug conjugate Trodelvy shows promise in slowing the progression of the most common forms of breast cancer.
The FDA clinical hold comes after Alpine reported a patient died during the NEON-2 trial.