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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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Big Pharma had plenty of drama to keep journalists busy this quarter, which painted an accurate portrait of the wild and wonderful world of biopharma.
Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount.
BMS has so far been on a winning streak in the contingent value right cases, which allege that the pharma intentionally delayed regulatory activities for Breyanzi in order to avoid a $6.4 billion payout to Celgene shareholders.
Gilead’s layoffs include 72 employees at its Seattle location, which will close. Kite will shut down its Philadelphia facility. The layoffs are attributed to aligning resources with long-term strategic goals.
The November layoffs are the second known workforce reduction this year for Marinus Pharmaceuticals, which previously announced disappointing Phase III results for ganaxolone in two clinical trials.
Allogene is ceasing enrollment in a Phase I trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia after Bristol Myers Squibb’s Breyanzi was approved in the indication earlier this year.
Despite recent enthusiasm around the PD-1/VEGF space, BMO Capital Markets analyst Evan Seigerman noted that Merck’s pact with LaNova Medicines is more “conservativism” on the pharma’s part than confirmatory of recent data in the drug class.
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GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.