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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.
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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.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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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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The CDC accepted the recommendation of its advisory committee that the shot be delayed for many patients until they are at least two months of age due to safety concerns. The CDC itself has said the vaccine is safe and effective.
BMS is Harbour’s second powerhouse partner this year after the Chinese biotech signed a potential $4.68 billion deal with AstraZeneca in March.
Despite falling short of its primary Phase II objective, Nektar plans to push its T cell stimulator rezpeg into Phase III development.
Roche CEO Thomas Schinecker said during the company’s Q3 call that it is “not done” with deals—a promise he delivered on with Tuesday’s solid tumor pact with AI-focused Caris Life Sciences.
The FDA rejected the use of Exdensur, however, for chronic rhinosinusitis with nasal polyps.
Addition joins a growing list of launches this year, following in the footsteps of startups like Crystalys Therapeutics and Ollin Biosciences.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
Biotech’s slump may finally be over in 2026. In interviews with BioSpace, Zymeworks’ CEO Ken Galbraith and Zai Lab’s President and COO Josh Smiley explain what’s fueling the comeback.
2026 is set to be a banner year for M&A in biopharma, as buyers facing major patent cliffs fight for a small pool of late-stage assets.
Metsera showed the biopharma world that M&A is back. Who could be next?