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2,381 stories matching this filter · ← front page

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  • JAK inhibitor sequencing and transplant timing in myelofibrosis discussed at 2026 conference
    Dr. Andrew Kuykendall of Moffitt Cancer Center explained how doctors decide the order of JAK inhibitor therapies and when to consider allogeneic stem cell transplant for myelofibrosis patients. At…
    onclive · 6mo agoNeutral↗ source
  • Experts Highlight Emerging Strategies and Unmet Needs in Mantle Cell Lymphoma
    Dr. Lore Gruenbaum, PhD, recently discussed the evolving landscape of mantle cell lymphoma (MCL) in a presentation titled “New Understandings of Treatments, End Points, and Disease Biology Expand M…
    onclive · 6mo agoNeutral↗ source
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Simlukafusp Alfa plus atezolizumab shows safety but no benefit over standard care in metastatic kidney cancer
A clinical study evaluated the novel immunocytokine simlukafusp alfa combined with atezolizumab, with or without bevacizumab, in patients with unresectable metastatic renal cell carcinoma. The com…
onclive · 6mo agoNegative readoutNeutral↗ source
  • Intercept’s next-generation FXR agonist INT-787 fails Phase 2 trial in alcohol-associated hepatitis
    Intercept Pharmaceuticals reported that its experimental FXR agonist INT-787 did not demonstrate efficacy in a Phase 2 study of patients with severe alcohol-associated hepatitis. The trial results…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Study links specific dietary fats to pancreatic cancer risk, highlighting oleic acid as promoter and omega-3s as protective
    Researchers at Yale Cancer Center examined how different types of dietary fat affect pancreatic cancer development in a mouse model. Rather than focusing on total fat intake, the study compared twe…
    onclive · 6mo agoNeutral↗ source
  • Experts stress seamless coordination for relapsed multiple myeloma patients across academic and community clinics
    In a recent opinion segment, Dr. Ajay K. Nooka convened a discussion with Dr. Noopur S. Raje and Dr. Surbhi Sidana about how to best coordinate care for patients with relapsed and refractory multip…
    onclive · 6mo agoNeutral↗ source
  • Patient with EGFR-mutated NSCLC develops brain metastases after first-line EGFR inhibitor and chemotherapy
    Dr. Sands presented a case of a patient with metastatic non-small cell lung cancer that carries an EGFR mutation. The patient was treated with a first-line regimen that combined an EGFR tyrosine k…
    onclive · 6mo agoNeutral↗ source
  • Celcuity reports positive Phase 3 results for gedatolisib in PIK3CA-mutant breast cancer
    On May 4, 2026 Celcuity announced that its experimental drug gedatolisib achieved success in two treatment regimens for patients whose tumors carry PIK3CA mutations, according to data from its ongo…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • UCB commits $2 billion to Candid's T cell engager program for autoimmune diseases
    UCB, a long standing European pharmaceutical company, announced a $2 billion investment in Candid, a biotech focused on T cell engager therapies aimed at autoimmune conditions. The deal reflects U…
    Endpoints · 6mo agoDealPositive↗ source
  • Supreme Court reverses stay, allowing mail ordering of abortion pill mifepristone
    The U.S. Supreme Court issued a decision on Monday that restores the ability to order the abortion medication mifepristone by mail. This action overturns a stay that had been placed by a federal ap…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • Swiss biotech Windward Bio raises $165 million to launch Phase 3 asthma trial for China-derived drug
    Swiss biotech Windward Bio announced it has secured $165 million in financing. The capital will be used to move one of its two experimental medicines, originally discovered in China, into a Phase…
    Endpoints · 6mo agoDealPositive↗ source
  • 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
  • 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
  • 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
  • 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
  • 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