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1,948 stories matching this filter · ← front page

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  • 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
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  • 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
  • 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
  • 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
  • FDA oncology panel votes against AstraZeneca's camizestrant trial, citing lack of meaningful benefit
    The FDA's oncology advisory committee convened for the first time in about nine months and evaluated AstraZeneca's late-stage trial of its oral selective estrogen receptor degrader, camizestrant.…
    Endpoints · 6mo agoRegulatoryNegative↗ source