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2,175 stories matching this filter · ← front page

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  • FDA narrows search for new CBER chief to three or four finalists
    The FDA announced that its search for a new head of the Center for Biologics Evaluation and Research (CBER) has been narrowed. According to a source familiar with the process, the agency is now fo…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Biotech sees rise of lean startups backed by large funding and Chinese assets
    A new wave of biotech companies is emerging that prioritises lean organizational structures over extensive early‑stage research programs. These firms are being launched with modest employee counts…
    Endpoints · 4mo agoNeutral↗ source
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  • Bristol Myers faces pivotal year as Q1 earnings season begins
    The weekly Endpoints newsletter for the last week of April highlighted that several pharmaceutical companies released their first-quarter earnings. Among them, Bristol Myers was singled out as bei…
    Endpoints · 4mo agoEarningsNeutral↗ source
  • Bristol Myers shows modest revenue rise, Biogen beats forecasts, Regeneron outlook remains uncertain
    BioPharma Dive highlighted the latest quarterly earnings from three major biotech firms, noting how investors are interpreting the results. Bristol Myers Squibb reported $11.5 billion in revenue f…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • FDA approves Arvinas' PROTAC drug Veppanu for specific metastatic breast cancer
    U.S. regulators have granted approval for Veppanu, a protein-degrading therapy developed by biotech firm Arvinas, to treat a defined group of patients with metastatic, estrogen-receptor-positive, H…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • Summit Therapeutics' ivonescimab misses interim goal, shares tumble 27% as trial setback raises doubts
    Summit Therapeutics reported that its experimental immunotherapy ivonescimab failed to achieve statistical significance at an interim analysis of the late-stage HARMONi-3 trial in frontline non‑sma…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation
    The U.S. Food and Drug Administration has granted approval to Axsome Therapeutics’ oral medication Auvelity for the treatment of agitation in patients with Alzheimer’s disease. Axsome noted that a…
    Endpoints · 4mo agoApprovalPositive↗ source
  • Moderna discusses post-marketing data with FDA to expand Covid-19 vaccine label
    Moderna announced it is working with US regulators to supply post-marketing data on its Covid-19 vaccines. The effort aims to address the FDA's decision last year to narrow the vaccine label, limi…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • FDA greenlights Pfizer/Arvinas breast cancer therapy vepdegestrant despite modest trial results
    The U.S. Food and Drug Administration announced approval of vepdegestrant, a therapy developed by Pfizer and Arvinas, for a specific subtype of breast cancer. The decision comes even though the cl…
    Endpoints · 4mo agoApprovalNeutral↗ source
  • Amgen initiates three late-stage trials of obesity shot MariTide, including a switch-patient study
    Amgen announced the start of three new Phase 3 trials for its long-acting obesity injection, MariTide. One of the studies will enroll participants who are transitioning away from the GLP-1 therapi…
    Endpoints · 4mo agoCRLPositive↗ source
  • Moderna reports Q1 revenue surge driven by international COVID vaccine sales despite larger net loss
    Moderna posted first‑quarter revenue of $389 million, more than triple the same period a year earlier, primarily from overseas COVID‑19 vaccine sales. The company recorded a net loss of $1.3 billi…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Seaport Therapeutics jumps over 20% on Nasdaq debut as former Karuna team outlines CNS research plans
    Seaport Therapeutics began trading on Nasdaq on May 1, 2026, ringing the opening bell. Its shares surged more than 20% on the first day. The company’s leadership, including the CEO and CSO, highli…
    Endpoints · 4mo agoPositive↗ source
  • Samsung Biologics workers launch five-day strike over wage dispute
    On May 1, 2026 union workers at Samsung Biologics began a five-day strike after a rally in April. The walkout is over wage negotiations, with about 95% of the company's union members voting in fav…
    Endpoints · 4mo agoNegative↗ source
  • Cue Biopharma names Shao‑Lee Lin CEO and licenses new allergy asset from Taiwan and China
    Cue Biopharma announced a reboot, bringing in biotech veteran Shao‑Lee Lin as its new chief executive. Lin, founder of Acelyrin, will lead the Boston‑based company as it expands its pipeline. The…
    Endpoints · 4mo agoDealPositive↗ source
  • Premium subscribers invited to exclusive post-hoc Q1 earnings recap live event
    A live, post‑hoc session will be held for premium subscribers that reviews first‑quarter earnings across the pharmaceutical sector, with a particular focus on the deal activity reported in the call…
    Endpoints · 4mo agoNeutral↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$SMMT} tumbled nearly 20% after the closing bell Thursday afternoon, following an apparent statistical miss in part of a Phase 3 trial for its cancer drug ivonesci…
    Endpoints · 4mo ago↗ source
  • Amgen files update to Tavneos label as FDA escalates push to withdraw
    Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...
    Endpoints · 4mo ago↗ source
  • Seaport, Hemab price IPOs, while Avalyn soars in Nasdaq debut
    A trio of biotechs priced their IPOs on Thursday into Friday morning, setting the stage for their public trading debuts with more than $850 million combined. Seaport Therapeutics, Hemab Therapeutic…
    Endpoints · 4mo ago↗ source
  • J&J axes pair of CAR-T therapies for lymphoma, citing evolving market
    Johnson & Johnson is scrapping two CAR-T cell programs for B cell lymphoma amid a wave of approvals in recent years for cell therapies and antibody-based drugs addressing the disease. The drugmaker
    Endpoints · 4mo ago↗ source
  • Boehringer appoints pharma veteran for corporate affairs post; BlueRock CSO heads for the exit
    → Boehringer Ingelheim has brought in Christie Bloomquist as SVP, corporate affairs, US human pharma, and she’ll be president of the Boehringer Cares Foundation. Peer Review informed you about her…
    Endpoints · 4mo ago↗ source
  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    BioPharma Dive · 4mo ago↗ source
  • FDA's oncology advisors vote against 'new paradigm' in AstraZeneca trial
    In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn't show a “clinic…
    Endpoints · 4mo ago↗ source
  • Krazati fails confirmatory trial in colorectal cancer, putting approval at risk
    Bristol Myers Squibb’s cancer drug Krazati has failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News. Krazati had received accelerated a…
    Endpoints · 4mo ago↗ source
  • House panel calls to ban China data from FDA drug trial applications
    A powerful spending committee in Congress wants the FDA to ban the use of clinical trial data from China in future applications by drugmakers to test new treatments. The language was
    Endpoints · 4mo ago↗ source
  • Court dismisses part of Lilly lawsuit against Empower, some claims can proceed
    A federal judge has dismissed part of Eli Lilly’s lawsuit alleging Empower Pharmacy misled customers about its compounded versions of the obesity drug tirzepatide. But the court said some of Lilly’…
    Endpoints · 4mo ago↗ source