The Latest

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    The FDA was all in on AI. Will that change?

    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

    FDA
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    Sponsored by ICON

    From confidence to capital: Positioning biotech for the next growth cycle

    How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.

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    Trump administration

    5 FDA decisions to watch in the third quarter of 2026

    A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.

    FDA
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    AbCellera, Vertex partner on next-gen T-cell engagers

    The deal adds to a growing streak of partnerships involving new types of T cell engagers and gives Vertex another chance to broaden a business still reliant on cystic fibrosis medicines.

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    Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEO

    Most recently the leader of buzzy startup Tessera Therapeutics, Severino will look to improve the fortunes of a company facing emerging competition and declining sales for its prized gene therapy Elevidys.

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    News roundup

    FDA scientists question Capricor data; Legend CEO steps down

    Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation extended a stock slide for Legend and AstraZeneca disclosed more pipeline trouble.

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    Brain drug revival

    MapLight dives despite positive data for schizophrenia drug

    Shares fell more than 66% Monday morning, which analysts suspect is due to investors seeing the data as not competitive with Bristol Myers' Cobenfy.

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    Trump administration

    FDA panel endorses broader use of certain peptides

    In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supporting their benefits and safety.

    Updated July 26, 2026
    FDA
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    Argenx to acquire Forte in $2.2B deal for ‘differentiated’ immune drug

    The deal gives Argenx a drug prospect aimed at the protein target CD122, an approach that’s recently gained traction among multiple developers.

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    Sanofi halts development of troubled immune drug in eczema

    The decision to no longer seek approval of amlitelimab is the latest setback for a treatment once hailed as a future blockbuster. One analyst expects Sanofi to now pursue “strategic action” to boost its pipeline.

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    IPO window

    Scribe secures $129M in a rare gene editing IPO

    The startup is the first gene editing company to price an IPO in more than two years, though it banked far less than most other biotechs that have gone public in 2026.

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    Obesity drugs

    Lilly, with new data, to seek FDA approval of obesity drug retatrutide

    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.

    FDA
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    Deep Dive

    Biotech M&A is accelerating. Track the deals that are happening here.

    Argenx is paying $2.2 billion to acquire Forte Biosciences, the developer of a CD122-targeting antibody drug that’s shown early promise against multiple immunological conditions.

    Updated July 27, 2026
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    Vertex was sole bidder in high-premium Crinetics acquisition

    Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.

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    Deep Dive // IPO window

    Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

    Apnimed on Monday outlined terms for an offering that, at its midpoint, values the sleep drugmaker at over $600 million.

    Updated July 28, 2026
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    News roundup

    Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma

    Novo is seeking an injunction that would halt allegedly “misleading” obesity drug ads. Elsewhere, the FDA began reviewing a highly anticipated medicine and a veteran investor landed at an AI startup.

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    GSK lung cancer drug gets speedy approval following $10.6B deal

    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.

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    Obesity drugs

    Novo sues Lilly, alleging ‘misleading’ advertising of obesity drugs

    The lawsuit follows a cease-and-desist request and argues Lilly is using “deceptive” ads to claim its GLP-1 products are broadly superior to Novo’s medicines. Lilly countered that its campaign is “truthful.”

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    Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug

    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.

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    Trump administration

    Trump threatens tariffs on imported generic drugs

    While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove more disruptive.

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    Emerging biotech

    Dimension restocks with $800M to capitalize on AI’s ‘rapid ascent’

    The young venture firm, which has bet heavily on tech and biotech’s convergence, has now invested in 35 companies and recently saw one of them acquired by AI giant Anthropic.

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    Emerging biotech

    Crystalys nets $130M more to push gout drug through late-stage tests

    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in the U.S. or Europe.

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    News roundup

    Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study

    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competitor emerged.

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    Novartis climbs on upbeat drug sales as key readouts loom

    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.

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    Agios scraps sickle cell drug

    The study failure costs Agios a chance to one-up Novo Nordisk and represents yet another setback in a disease that’s frustrated drugmakers of late.

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    IPO window

    Pain drugmaker Latigo outlines plans to go public

    The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.