The Latest

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    5 FDA decisions to watch in the second quarter of 2026

    The next three months will bring more tests of regulatory flexibility, as well as decisions on closely watched medicines for obesity, Alzheimer’s and cardiovascular disease.

    Updated March 30, 2026
    FDA
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    News roundup

    Replimune cuts staff; MeiraGTx reacquires eye gene therapy

    Replimune is laying off 63 staffers days after the second FDA rejection of its melanoma drug. Elsewhere, Revolution raised $2 billion and a regulatory filing revealed details on negotiations between Biogen and Apellis.

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    Obsidian, Galera to advance cell therapy following reverse merger

    The combined company will trade on the Nasdaq under the ticker OBX. It has also secured commitments for a private placement expected to deliver $350 million in gross proceeds.

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    FDA asks Lilly to evaluate obesity pill’s liver risk

    The request, which is part of a just-released approval letter for Foundayo, comes amid an intensifying marketing battle between Lilly and Novo.

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    J&J leans on Tremfya, cancer drugs to overcome Stelara losses

    A growing multiple myeloma franchise helped the pharmaceutical giant top Wall Street’s expectations and surpass $15 billion in first-quarter drug sales.

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    Lilly boosts ADC portfolio with CrossBridge Bio deal

    Worth up to $300 million, the buyout is Lilly’s latest of an ADC maker and adds technology for making “dual-payload” therapies.

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    Revolution pancreatic cancer drug nearly doubles survival in key trial

    The subject of buyout rumors this year, Revolution posted Phase 3 results one analyst called a “game changer” in a tough-to-treat tumor. 

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    Travere wins long-awaited approval for kidney disease drug

    The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually. 

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    Deep Dive // IPO window

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

    Brain drug developer Seaport Therapeutics and blood disease specialist Hemab Therapeutics joined the queue, while obesity biotech Kailera Therapeutics set terms for a potential $500 million offering.

    Updated April 12, 2026
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    Allogene data suggest ‘off-the-shelf’ CAR-T could delay relapse in lymphoma

    Initial results from a high-stakes trial indicate the biotech may have finally found a niche in lymphoma care for a donor-derived cell therapy. 

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    Deep Dive

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

    Gilead on Tuesday announced its third company acquisition since late February, agreeing to pay up to $5 billion to acquire Tubulis, a startup developing antibody-drug conjugates for cancer.

    Updated April 7, 2026
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    News roundup

    Novo teams with OpenAI; Ideaya gets muted response to eye drug data

    Novo intends to “fully integrate” AI capabilities across its operations. Elsewhere, Regeneron made its first foray into radiopharmaceuticals and a GSK cancer drug showed early promise.

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    Spyre drug for inflammatory bowel disease shows promise in early study

    The therapy, which works similarly to Takeda’s blockbuster Entyvio, showed remission rates that suggest a “best-in-class” profile, the company said. 

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    FDA again spurns Replimune melanoma drug

    In a statement late Friday, CEO Sushil Patel disputed the FDA’s criticisms of the company and said Replimune had received “inconsistent communications.” It’ll be forced to cut jobs as well.

    Updated April 13, 2026
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    Deep Dive // Emerging biotech

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

    Three cancer drug developers, including Oricell, raised nearly $350 million in combined funding last week in an early surge to start the second quarter.

    Updated April 10, 2026
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    Oricell closes a ‘pre-IPO’ megaround to aim CAR-T at solid tumors

    The Shanghai-based biotech has a cell therapy that, if successful in testing, could become the first treatment of its kind for liver cancer. 

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    Women have awaited a revolution in menopause. It hasn’t arrived.

    Persistent barriers are still hindering drug development for a host of menopause symptoms.

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    News roundup

    RFK Jr. rewrites ACIP rules; Gilead, Roche dig into protein degraders

    The newly published charter widens the required expertise to become an ACIP member and stresses vaccine safety. Elsewhere, Gilead licensed a Kymera drug and a new RNA-focused startup emerged. 

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    China competition

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

    Sanofi reached a deal for rights to a drug already on the market in China, while UCB is the latest to bet on the ability of T cell engagers to treat autoimmune conditions.

    Updated March 4, 2026
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    Vaccines

    Invivyd reveals plans to test an antibody drug against measles

    The drug, which Invivyd sees as a potential treatment and “targeted alternative” for the vaccine-hesitant, comes as measles cases in the U.S. are reaching levels not seen in decades. 

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    Courtesy of Eli Lilly
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    Obesity drugs

    Lilly launches GLP-1 pill, kicking off showdown with Novo Nordisk

    After winning the battle for injectable obesity medicines, Lilly hopes Foundayo can help it catch up in the oral market, where Novo has a three-month lead.

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    IPO window

    Chasing a tough-to-treat lung disease, Avalyn plans an IPO

    Backed by Novo Holdings and multiple other prominent investors, the biotech is developing what it’s positioning as superior versions of entrenched — but flawed — medicines for idiopathic pulmonary fibrosis.

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    With 3 quick buyouts, Gilead leans into its latest transformation

    On a conference call with analysts, Gilead walked through how a string of recent deals focused on cancer and autoimmune conditions could help a diversification plan it’s long struggled to execute.

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    Vaccines

    Activist investor revives campaign to overhaul Novavax board

    Shah Capital, which has agitated for change at the vaccine maker for years, is calling on fellow shareholders to end what it calls “dogmatic leadership” that’s led to the “destruction” of Novavax’s equity value. 

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    Emerging biotech

    Jeito Capital, prominent biotech investor, raises $1.2B for next fund

    Jeito claimed the new bankroll, which will support 15 to 20 clinical-stage companies, is the largest ever for a “fully independent European fund dedicated to biopharma.”