The Latest

  • 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.

    Following Apnimed’s $192 million raise last Thursday, five other drugmakers have set IPO terms. All five, including Braveheart Bio and Latigo Biotherapeutics, could price offerings this week.

    Updated Aug. 3, 2026
  • An Alnylam logo is displayed on a building in Cambridge, Massachusetts, on Sept. 5, 2024.
    Image attribution tooltip
    Jacob Bell/BioPharma Dive
    Image attribution tooltip

    Alnylam plunges as earnings deliver ‘one-two punch’

    The RNA-focused biotech shed 30% of its market value — or close to $12 billion — amid growing investor concerns about its main drug business.

  • Sign reads "wall street" with "stock exchange" engraved on a building in the background.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Supernus, Indivior merge to beef up brain drug portfolio

    The transaction combines two companies marketing nearly a dozen neurological drugs that bring in steady, but not blockbuster sales for conditions such as opioid use disorder and Parkinson's.

  • A BioNTech logo hangs on the side of an office building.
    Image attribution tooltip
    Sean Gallup via Getty Images
    Image attribution tooltip

    BioNTech taps Sobi executive Oelkers as its next CEO

    Guido Oelkers will guide BioNTech’s ongoing transition into an oncology-focused biotech, while co-founder and longtime leader Ugur Sahin prepares to join a fledgling mRNA startup.

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

    Novo setback casts doubt on a new way to treat heart disease

    Ziltivekimab's failure in a key trial spurred share sell-offs for Novo and other biotechs, as it suggested trouble for different cardiovascular drugs that also target inflammation.

  • Bunches of pills in varied colors are organized in containers.
    Image attribution tooltip
    Fotografia Basica via Getty Images
    Image attribution tooltip

    Trump administration tries again to institute rebates in 340B

    The Health Resources and Services Administration is again pushing to include rebates in the drug discount program after a failed attempt earlier this year. Hospitals railed against the announcement, saying it would burden already strapped providers.

  • Resilience's headquarters in Blue Ash, Cincinnati.
    Image attribution tooltip
    Courtesy of Resilience
    Image attribution tooltip

    Resilience and Lilly invest $750M to boost Cincinnati drug production

    The expansion will create 400 jobs dedicated to making GLP-1 injectables across Resilience’s contract manufacturing facilities.

  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Replimune melanoma drug wins support of FDA panel

    The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.

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

    Sanofi to ‘rebuild trust’ with Regeneron; Apnimed adds to string of ‘upsized’ biotech IPOs

    Sanofi wants to broaden the company’s productive partnership with Regeneron, its CEOs said. Elsewhere, Bristol Myers delayed two anticipated study readouts and a Shionogi-backed startup went public.

  • Johnson & Johnson's pharmaceutical office in Madrid, Spain.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Emerging biotech

    J&J nabs option to buy ‘in vivo’ CAR-T maker Sail for nearly $2.6B

    The deal with the buzzy Flagship Pioneering-backed startup makes J&J the latest large drugmaker to bet that the technology might be able to treat autoimmune conditions.

  • Wall Street buildings
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push

    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.

  • An illustration of two neurons, colored blue and purple
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Q&A

    MapLight CEO on what investors missed in the biotech’s schizophrenia data

    Though positive, mid-stage study results erased about two-thirds of the biotech's market value this week. But Christopher Kroeger sees MapLight's drug as competitive based on the "totality of data."

  • An illustration of necrotic muscle fiber in Duchenne muscular dystrophy.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Capricor Duchenne cell therapy voted down by FDA panel

    At a contentious meeting with possible implications for other rare disease drugmakers, outside experts ultimately determined that Capricor didn't prove deramiocel's benefits in Duchenne-related cardiomyopathy.

    FDA
  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
    Image attribution tooltip
    Alamy
    Image attribution tooltip
    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
  • Hims & Hers Super Bowl ad header
    Image attribution tooltip
    Courtesy of Hims & Hers
    Image attribution tooltip

    FTC sues Hims & Hers over alleged privacy violations, deceptive billing practices

    Regulators say the telehealth company illegally shared patients’ health data with advertisers and misled its customers. Hims & Hers hit back, calling the claims “baseless.”

  • A street sign for Wall Street in front of the facade of the New York Stock Exchange.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Emerging biotech

    Caldera, Vidya add to recent flurry of biotech mergers

    The startups are part of a surge of young companies equipped with advanced drug prospects and quickly pivoting to the public markets.

  • A person in a lab coat is seen through a well-lit, organized laboratory environment featuring shelves stocked with additional lab supplies and instruments.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

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

    GSK prepares for patent cliff with $2.5B cost-cutting plan

    The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss of patents important to its HIV drug franchise.

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

    FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data

    Replimune shares plummeted 40% on concerns FDA scientists are still skeptical of its melanoma drug. Elsewhere, investors had a muted reaction to a first-of-its-kind study result.

  • Vertex bldg
    Image attribution tooltip
    Permission granted by Vertex Pharmaceuticals
    Image attribution tooltip

    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.

  • A red magnifying glass sits on top of cash.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Emerging biotech

    An eye drug biotech banks $118M and stocks its executive suite

    Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.

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

    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.

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

  • Abstract financial graph with up trend line on neon light colour background
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    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.

  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    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