The Latest

  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
    Image attribution tooltip
    Kendall Davis/BioPharma Dive
    Image attribution tooltip
    Tracker

    10 clinical trials to watch in the second half of 2026

    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.

  • An exterior photo of Seattle Children's Hospital.
    Image attribution tooltip
    Courtesy of Seattle Children's Hospital
    Image attribution tooltip

    BrainChild hauls in $116M to make cell therapies for childhood brain cancers

    Spun out of research at Seattle Children’s Hospital, the startup has brought a CAR-T treatment for a rare and deadly pediatric cancer into mid-stage testing.

  • A stack of newspapers are seen against a blue background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    News roundup

    Ionis’ rare neurology drug approved; Pfizer inks an ADC deal

    Zanvastro is now the first approved medicine for Alexander disease. Elsewhere, an immune system specialist posted positive results and a cell therapy developer turned to layoffs.

  • The AbbVie logo is prominently displayed on the facade of a sleek, contemporary building surrounded by a clear blue sky.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Trailing rivals, AbbVie scores win with dual-acting myeloma drug

    The drugmaker is leaning on a better side effect profile compared to drugs from J&J, Pfizer and Regeneron as it pushes etentamig toward FDA submission.

  • A technician in protective clothing stands beside manufacturing equipment in a pharmaceutical laboratory.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    The hidden scale-out problem behind CAR-T’s growth

    CAR-T’s commercial challenge is making thousands of patient-specific manufacturing runs behave like one reliable system. "In vivo" production techniques could be one solution.

  • An Ultragenyx sign is seen on the side of an office building.
    Image attribution tooltip
    Permission granted by Ultragenyx
    Image attribution tooltip

    Ultragenyx to weigh ‘significant’ cost cuts as Angelman drug fails key study

    The failure of what was once considered a potential blockbuster therapy represents a major setback in a tough-to-treat disease and is forcing Ultragenyx to closely examine its expenses.

  • CAR-T cell therapy uses the body as a manufacturing site to fight cancer
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Immune reset

    Novartis, Bristol Myers pause autoimmune CAR-T trials due to safety concerns

    The deaths of three study participants led Novartis to halt development of rap-cel in multiple indications, while “transient” side effects pushed Bristol Myers to voluntarily pause its zola-cel program.

    Updated Sept. 1, 2026
  • An illustration of two immune checkpoint proteins binding
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Akeso, Summit cancer drug confirms lung cancer survival benefit

    A new data cut of a trial pitting ivonescimab, a bispecific antibody, against Merck’s Keytruda showed the new drug helped people live longer.

  • An illustration of dopamine outside the cell binding to a receptor.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Emerging biotech

    An AI drug specialist zeroes in on rare forms of obesity

    Superluminal Medicines banked $60 million in funding to support development of a drug designed to work similarly to — but potentially be more selectively than — Rhythm Pharmaceuticals’ marketed medicine Imcivree.

  • An anatomical model of the heart sits on a desk in a doctor's office
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    ESC ‘26: Cytokinetics’ sell-off, Arrowhead’s edge and a heart drug autopsy

    At a big meeting for cardiovascular medicines, Cytokinetics and Arrowhead aimed to separate their drugs from competitors while a failed study pressured Alnylam.

  • A sign with the letters GSK hangs on the side of an office building.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    China competition

    GSK wagers up to $1.3B on a different kind of cancer drug

    With its latest foray into China, GSK acquired rights from Hutchmed to an “antibody-targeted therapy conjugate” impacting two well-known cancer drivers, EGFR and KRAS.

  • A sign for the Food And Drug Administration is seen
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    UniQure, after setbacks, seeks FDA approval of Huntington’s gene therapy

    The company is now hoping for an affirmative answer on its application after an unusually turbulent year dealing with U.S. regulators.

  • A sign spelling Novartis hangs on the side of a building.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Novartis says MS pill succeeds in two large studies

    Notably, Novartis revealed that remibrutinib wasn’t associated with the kind of liver-related side effects other BTK inhibitors like it have encountered.

  • A technician wearing a blue mask works in a laboratory.
    Image attribution tooltip
    Kevin Frayer via Getty Images
    Image attribution tooltip
    China competition

    Drugs from China are reshaping biotech. Track the licensing deals here.

    Including a new deal with Roche last week, Simcere Pharmaceutical has now inked five cross-border licensing pacts since the start of 2025 that are collectively worth up to $5.66 billion.

    Updated Sept. 2, 2026
  • A stack of newspapers are seen against a blue background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    News roundup

    Teva claims success in celiac study; BioMarin, Ascendis settle patent dispute

    Teva believes the therapy has “pipeline-in-a-product” potential. Elsewhere, a high-stakes trial was paused and GSK advanced a competitor to Moderna’s flu shot.

  • The North Lawn at the White House in Washington, D.C.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Trump administration

    Mid-cap biotechs join Trump’s latest round of drug pricing deals

    Focused on Medicaid, the new pacts now involve more than just large pharmaceutical companies, but still aren’t expected to meaningfully impact drugmaker profits.

  • A falling line on a stock chart.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Alumis’ TYK2 drug fails in key lupus study

    Though Alumis still sees a path forward in lupus, the result made its drug the latest TYK2 blocker to struggle in conditions beyond psoriasis and psoriatic arthritis. 

  • A double exposure image of a glass flask in a laboratory with stock market information in the background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    This week in charts: Biotech’s rebound is undeniable

    Not only is the XBI continuing to hover around a historic high, but drug companies can’t seem to get enough of both large IPOs and big-ticket M&A.

  • Illustration of an antibody (immunoglobulin) molecule, showing its Y-shaped structure
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Lilly adds to immune drug pipeline with $2.9B Merida buyout

    The big drugmaker’s latest company acquisition this year is centered around a technology designed to degrade proteins that malfunction in autoimmune disorders.

  • A photo of the packaging for the pancreatic cancer drug Rasonque
    Image attribution tooltip
    Retrieved from Revolution Medicines.
    Image attribution tooltip

    Revolution pancreatic cancer drug should quickly become a blockbuster, analysts say

    Rasonque’s $39,800 monthly list price surpassed Wall Street forecasts and led to rosier sales projections ahead of what one analyst described as a “historic” launch.

  • A thumbnail illustration for BioPharma Dive's IPO tracker
    Image attribution tooltip
    Adeline Kon/BioPharma Dive
    Image attribution tooltip
    Deep Dive // IPO window

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

    ADARx Pharmaceuticals, which is testing RNA interference drugs for conditions ranging from rare genetic disorders to kidney diseases to stroke prevention, has filed plans for an IPO.

    Updated 17 hours ago
  • A Takeda logo is displayed on a building in Cambridge, Massachusetts, on Sept. 5, 2024.
    Image attribution tooltip
    Jacob Bell/BioPharma Dive
    Image attribution tooltip

    FDA OKs Takeda, Protagonist drug for rare blood cancer

    The clearance and broader-than-expected label for Mimrylo open up a yearly revenue opportunity for Takeda that some analysts expect to reach $2 billion or more. 

    FDA
  • Heart
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    AstraZeneca, Ionis data spark debate about RNA drugs’ impact on deadly heart disease

    Results published in NEJM raised questions about the benefits “silencer” medications provide on top of standard therapies for TTR cardiomyopathy and amplified investor pressure on Alnylam.

  • A bottle of brepocitinib, also known as Lisraya, Priovant's drug to treat the rare skin disease dermatomyositis.
    Image attribution tooltip
    Courtesy of Priovant Therapeutics
    Image attribution tooltip

    FDA green lights Priovant drug for rare skin disease

    Lisraya’s clearance marks the first approval of a drug the Roivant subsidiary licensed from Pfizer and has since positioned against multiple rare inflammatory conditions.

    Updated Aug. 28, 2026
  • A headshot of Michael Polansky, co-founder and CEO of Outer Bio
    Image attribution tooltip
    Permission granted by Outer Bio
    Image attribution tooltip
    Q&A // Emerging biotech

    Michael Polansky has a new, skin-focused biotech. Don’t call it a drug company.

    Though its data could be useful for pharmaceutical firms, Polansky’s latest entrepreneurial endeavor, Outer Bio, is serious about steering clear of road bumps that slow biotechs.