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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 · 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
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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 · 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
  • 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoPositive↗ 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 · 6mo agoDealNeutral↗ source
  • Court dismisses portion of Eli Lilly lawsuit against Empower Pharmacy, leaves some claims alive
    A federal judge ruled that part of Eli Lilly's lawsuit against Empower Pharmacy is dismissed. The suit alleged that Empower misled patients about its compounded versions of tirzepatide, an obesity…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • CVS Health explores clinical AI but cites barriers to broader use
    CVS Health's President of Health Care Delivery Sree Chaguturu discussed the company's ongoing experiments with artificial intelligence tools aimed at delivering clinical services. The testing has…
    Endpoints · 6mo agoNeutral↗ source
  • Investors at Boston Digital Healthcare Innovation Summit focus on emerging health tech opportunities
    The reporter attended the Digital Healthcare Innovation Summit in Boston earlier this week, gaining a firsthand view of investor perspectives on health technology. Attendees heard that investors a…
    Endpoints · 6mo agoNeutral↗ source
  • The R&D 15: How pharma's top companies spent, won and lost on drug research
    Talking over pharma pipelines with a major drugmaker's development chief, he noted that if you looked at the biggest 50 drugs by revenue, the final one on the list brought in about $4 billion last ...
    Endpoints · 6mo agoNeutral↗ source
  • Pfizer reports positive Phase 3 results for Elrexfio in relapsed multiple myeloma
    Pfizer announced that its antibody-drug conjugate Elrexfio achieved a statistically significant and clinically meaningful improvement in progression-free survival for patients with relapsed or refr…
    Endpoints · 6mo agoPositive readoutPositive↗ source