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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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Erica Schwartz, a former deputy surgeon general and member of the U.S. military, will take over from what has amounted to a rapid succession of CDC leaders over the past year.
Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program.
With Health Secretary Robert F. Kennedy Jr. declaring himself “a big fan of peptides,” the FDA has arranged an advisory committee to discuss allowing compounders to make molecules despite earlier safety concerns.
J&J will hand over the rights to bota-vec for $25 million upfront, clearing MeiraGTx to seek regulatory approvals in the U.S. and EU in 2027.
Right after the FDA flagged safety concerns for Eli Lilly’s newly approved obesity pill, the pharma posted diabetes data demonstrating a clean safety profile and revealed plans to seek approval in the indication.
Despite exceptional regional hubs and research strength, investors say Europe still needs more integrated incubators, smarter regulation and broader pools of patient capital to keep breakthrough companies growing at home.
Commitments in obesity- and diabetes-focused deals reached $22 billion in the first quarter of 2026—already eclipsing last year’s total of $20.3 billion, according to a new J.P. Morgan report.
After Revolution Medicines’ drug candidate doubled survival in a Phase 3 pancreatic cancer study, the biotech is hoping to attract more investor money, with new plans for a $2 billion stock and debt offering.
In recent months, Anthropic has been building more and more ties with the biopharma industry, including partnerships with Big Pharma companies such as Sanofi, Novo Nordisk and AbbVie.
The trend of fewer companies letting employees go, which began in the fourth quarter of last year, has continued. However, more employees were on the chopping block in Q1 2026 than in Q1 2025, due mainly to one company’s cuts.