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2,374 stories matching this filter · ← front page

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  • Vertex halts mRNA cystic fibrosis program citing tolerability concerns
    Vertex Pharmaceuticals announced it is ending development of its mRNA-based cystic fibrosis therapy after encountering tolerability problems that echo challenges seen elsewhere in the field. The B…
    Endpoints · 6mo agoNegative↗ source
  • 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 · 6mo agoRegulatoryNeutral↗ source
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  • 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 · 6mo agoNeutral↗ source
  • 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoApprovalPositive↗ source
  • Summit Therapeutics shares tumble 20% after interim Phase 3 miss for ivonescimab
    Summit Therapeutics saw its shares fall about 20% after the market close on Thursday. The decline came after an interim analysis of a Phase 3 trial for its cancer candidate ivonescimab failed to m…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Two biotech firms raise $556 million in combined IPOs
    Seaport Therapeutics and Hemab Therapeutics launched initial public offerings on Thursday, together bringing in $556.4 million to fund further development of their drug pipelines. Hemab Therapeuti…
    BioPharma Dive · 6mo agoDealPositive↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoEarningsNeutral↗ source
  • Seaport and Hemab price IPOs as Avalyn soars on Nasdaq debut
    Three biotechnology companies announced the pricing of their initial public offerings between Thursday and Friday, collectively targeting more than $850 million in proceeds. Seaport Therapeutics a…
    Endpoints · 6mo agoDealPositive↗ 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 · 6mo 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 · 6mo 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 · 6mo agoDealPositive↗ source
  • Amgen files label update for Tavneos as FDA intensifies withdrawal push
    Amgen has submitted a supplemental filing to the FDA to revise the prescribing information for its osteoporosis drug Tavneos. The amendment adds expanded safety warnings as the agency escalates it…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • Johnson & Johnson drops two CAR-T lymphoma programs as market competition intensifies
    Johnson & Johnson announced it is discontinuing two CAR-T cell therapy programs aimed at treating B-cell lymphoma. The decision comes as the market for lymphoma treatments has become crowded, with…
    Endpoints · 6mo agoNegative↗ source
  • Boehringer Ingelheim names Christie Bloomquist as SVP of US corporate affairs and head of its Cares Foundation
    Boehringer Ingelheim announced that Christie Bloomquist has been appointed senior vice president of corporate affairs for its U.S. human pharmaceutical business. In addition to overseeing corporat…
    Endpoints · 6mo agoNeutral↗ 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 · 6mo agoNeutral↗ source
  • Eli Lilly beats forecasts with 56% revenue jump, lifts full-year outlook
    Eli Lilly reported first‑quarter revenue of $19.8 billion, up 56% year over year, and net income of $7.4 billion, or $8.26 a share. Non‑GAAP earnings were $8.55 a share, well above the $6.77 consen…
    BioPharma Dive · 6mo agoEarningsPositive↗ source
  • BMS's Krazati fails confirmatory colorectal cancer trial, jeopardizing its accelerated approval
    Bristol Myers Squibb said its drug Krazati did not meet the primary endpoint in a confirmatory study for second‑line colorectal cancer. The trial was required to verify the benefit that earned the…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • House panel urges FDA to bar Chinese clinical trial data from drug applications
    A House spending committee introduced language urging the FDA to prohibit the use of clinical trial data generated in China when reviewing new drug applications. The proposal reflects concerns abo…
    Endpoints · 6mo agoRegulatoryNegative↗ source