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  • 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
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  • 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 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 · 4mo 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 · 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
  • 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoRegulatoryNegative↗ source
  • Merck remains optimistic on Terns leukemia drug despite new data
    Merck said Thursday that it still sees a compelling outlook for Terns' leukemia drug even after updated study data suggested it may be less differentiated. The updated data came from a trial of TE…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • UniQure to submit UK marketing application for Huntington's gene therapy AMT-130
    UniQure announced it will file a marketing application in the United Kingdom later this year for its gene therapy AMT-130 aimed at Huntington's disease. The filing follows a positive meeting with…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ 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 · 4mo agoRegulatoryNegative↗ source
  • Supreme Court hints at ruling in case over generics' use of skinny-label drugs
    Supreme Court justices have offered preliminary signals about how they may decide a contentious lawsuit that could reshape the way generic drug makers market products with "skinny labels". The cas…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Avalyn Pharma launches $300M IPO, selling 16.5 million shares at $18 each
    Avalyn Pharma, a Boston-based biotech, announced an initial public offering that aims to raise roughly $300 million. The company will sell more than 16.5 million shares at $18 per share and is set…
    Endpoints · 4mo agoDealNeutral↗ source
  • Analysts zero in on three Bristol Myers programs as company gears up for multiple data readouts through 2026
    Analysts are closely watching Bristol Myers Squibb's pipeline, focusing on three key programs that could drive growth in the coming years. Wall Street expects a flurry of data readouts, with at le…
    Endpoints · 4mo agoNeutral↗ source
  • Lilly’s obesity pill Foundayo sees slower early uptake than Novo’s, with only about 20,000 users in first 20 days
    Eli Lilly launched its obesity medication Foundayo recently, and the company reported that roughly 20,000 patients have started the treatment within the first 20 days. CEO David Ricks said this ea…
    Endpoints · 4mo agoNegative↗ source
  • Novartis announces new North Carolina manufacturing plant, completing its $23 billion U.S. expansion
    Novartis disclosed plans to construct another manufacturing facility in the United States, adding to its ongoing expansion program. The new plant will be located in North Carolina and represents t…
    Endpoints · 4mo agoPositive↗ source
  • Avalyn Pharma raises $300M in IPO to fund inhalable lung-fibrosis drugs
    Avalyn Pharma completed a $300 million initial public offering, pricing 16.7 million shares at $18 each and exceeding its original $200 million target. The proceeds will be used to develop inhalab…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • XTL Bio to acquire Psyga Bio, adding psychedelic manufacturing capability
    XTL Bio announced it will acquire all outstanding shares of Psyga Bio, a biotech focused on psychedelic therapies. The transaction gives XTL access to Psyga’s manufacturing facility, expanding its…
    Endpoints · 4mo agoDealNeutral↗ source