The Latest

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    Deep Dive // Emerging biotech

    Biotech startups are built on venture capital. Track funding rounds here.

    RA Capital has been the most active investor so far this year among the firms tracked by BioPharma Dive year, participating in 6 funding rounds all with at least $103 million in total proceeds.

    Updated 7 hours ago
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    Emerging biotech

    Altesa, run by former Trump official, raises $75M for well-traveled lung drug

    Led by Brett Giroir and GSK’s ex-chief medical officer, Altesa is advancing a medicine that’s changed hands multiple times and once failed a study in asthma.  

    Updated 4 hours ago
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    Vaccines

    FDA reverses course on Moderna’s flu vaccine

    In response to a query from BioPharma Dive, an HHS spokesperson said the FDA will “maintain its high standards during drug review and potential licensure stages.”

    Updated Feb. 19, 2026
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    Alamy
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    Psychedelics stocks rise as Compass’ psilocybin drug heads to FDA

    Shares of at least four other developers were up by mid-single digits to low-double digits at certain points on Tuesday.

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    Brain drug revival

    An Alzheimer’s startup emerges with $175M in venture backing

    Backed by Wellington, Sanofi Ventures and a division of J.P. Morgan, Korsana Therapeutics is studying a treatment originally developed by hub-and-spoke biotech Paragon Therapeutics.

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    Deep Dive // IPO window

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

    The latest biotech to outline IPO plans is EIR Biopharma, a eye disease-focused startup run by former leaders of Intercept Pharmaceuticals and Iovance Biotherapeutics.

    Updated Feb. 19, 2026
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    Compass, with Phase 3 hits, ready to take psilocybin to the FDA

    The company plans to meet with the FDA to discuss a rolling approval application for “COMP360,” a synthetic form of psilocybin that could become the first “classic” psychedelic cleared for the U.S. market.

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    Lilly to pay CSL $100M to license monoclonal antibody targeting IL-6

    The Australian company will retain rights for an end-stage kidney disease indication currently being tested in a Phase 3 trial while Lilly explores other uses.

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    FDA accepts BMS protein degrader for review; Disc rare disease drug rejected

    Cytokinetics’ heart disease drug secured European approval. Elsewhere, Teva and Sanofi reported longer-term data from an experimental therapy targeting ulcerative colitis and Crohn’s disease.

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    Ocular claims a win with eye drug data even as shares sink

    Investors were looking for a greater difference between Ocular’s experimental medicine and a low-dose version of Eylea, analysts said.

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    China competition

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

    Gilead Sciences became the latest company to strike a deal with a Chinese biotech, announcing Friday it will pay $80 million upfront to Genhouse Bio for a "synthetic lethality" cancer drug.

    Updated Feb. 17, 2026
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    Deep Dive

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

    The roughly $30 billion deal Merck had been discussing with Revolution Medicines before talks reportedly fell apart would’ve ranked as the largest drug company acquisition since Pfizer’s buyout of Seagen.

    Updated Jan. 26, 2026
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    Moderna shares jump as company affirms growth outlook

    The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.

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    Vertex’s CRISPR therapy rebounds in latest earnings

    Sales of Casgevy, a gene-edited treatment developed with CRISPR Therapeutics, more than tripled compared to the third quarter, a performance analysts saw as a bright spot in Vertex's report.

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    Ultragenyx cuts jobs as it seeks path to profit in 2027

    Another FDA knockback for a gene therapy has investors and analysts redrawing expectations for the rare disease drug developer.

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    Alex Wong via Getty Images
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    Sanofi, looking for more ‘rigor,’ swaps CEO Hudson for ex-Merck KGaA chief Garijo

    The move drew skepticism from investors despite multiple recent research setbacks that have left questions about Sanofi’s ability to confront Dupixent’s looming patent expiration.

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    Sarah Silbiger via Getty Images
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    FDA removes box warnings for 6 menopausal therapies

    The FDA has lifted longstanding and the most severe warnings off of hormone replacement therapies for menopausal women.

    FDA
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    HHS elevates officials into Kennedy’s inner circle in advance of midterms

    The HHS secretary has four new senior advisors to help him “move faster and go further” on his Make America Healthy Again agenda.

    FDA
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    Earnings roundup: Neurocrine slumps, Alnylam battles skeptics and Ascendis eyes a competitor

    Neurocrine and Alnylam each face investor questions about the growth potential of key franchises. Ascendis, meanwhile, saw an upbeat sales report overshadowed by the progress of an emerging rival. 

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    News roundup

    Lyell starts first-of-its-kind CAR-T trial; New coalition aims to boost European biotechs

    Lyell’s trial will test its experimental cancer cell therapy directly against marketed counterparts. Elsewhere, Biogen swapped board chairs and venture firms are joining up at a “pivotal time” for Europe.

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    BridgeBio scores with dwarfism drug, setting up showdown with BioMarin, Ascendis

    The latest in a string of clinical wins, the late-stage data gives the company strong footing to compete with BioMarin's top seller.

    Updated Feb. 12, 2026
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    Lowering drug costs is on Republicans’ minds. Democrats say GOP policies don’t help.

    At a House subcommittee hearing last week, lawmakers on both sides of the aisle decried the nation’s high drug costs, but Democrats argued Medicaid cuts and lapsed Affordable Care Act subsidies are worsening the problem.

  • A Moderna logo is displayed on a building in Cambridge, Massachusetts, on Sept. 5, 2024.
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    Jacob Bell/BioPharma Dive
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    Vaccines

    FDA refuses to review Moderna’s mRNA flu vaccine

    Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.

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    Obesity drugs

    Hims cancels plans to sell compounded GLP-1 pill after FDA backlash

    Hims said it “deciding to stop offering access” to the treatment following escalating legal threats — among them a patent infringement suit Novo Nordisk filed against the company on Monday.

    Updated Feb. 9, 2026
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    Seres to lay off staff, pause top program in latest reboot

    The microbiome specialist, which for years has struggled to stay afloat, is cutting its staff by 30% and focusing resources on earlier, immunology-focused research.