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  • 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 · 4mo 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 · 4mo agoApprovalPositive↗ source
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  • 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 · 4mo 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 · 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
  • 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
  • Axsome receives FDA nod for Alzheimer’s agitation treatment
    Axsome announced that the U.S. Food and Drug Administration granted it a nod for a therapy aimed at agitation associated with Alzheimer’s disease, according to the STAT+ report. The decision marks…
    STAT · 4mo agoApprovalPositive↗ source
  • FDA proposes removing obesity and diabetes drug ingredients from compounding substances list
    The U.S. Food and Drug Administration has issued a proposal to remove the active ingredients of widely used obesity and diabetes medicines from the list of substances that can be compounded. The ch…
    STAT · 4mo agoRegulatoryNeutral↗ 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
  • FDA drops Casey Means as surgeon general nominee, naming Fox News radiologist Nicole Saphier instead
    FDA withdrew the nomination of Casey Means for surgeon general and appointed Nicole Saphier, a radiologist and Fox News commentator. The switch underscores the administration’s limited sway in the…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Founder launches new biotech to scale personalized medicines after prior venture folded
    Julia Vitarello’s daughter Mila received a custom‑designed therapy for her rare mutation eight years ago, sparking Vitarello’s interest in individualized treatments. Her first company, EveryONE Me…
    STAT · 4mo agoNeutral↗ source
  • Ailux appoints former AstraZeneca executive Maria Belvisi as chief scientific officer
    Ailux announced the hiring of Maria Belvisi as its new chief scientific officer. Belvisi comes from AstraZeneca where she served as senior vice president of research and development for respirator…
    STAT · 4mo agoPositive↗ source
  • US fertility decline sparks debate over policy motives and family support
    The piece highlights growing alarm in the United States about a sustained drop in birth rates, pointing to factors such as costly childcare, unaffordable housing, shaky health‑care access, and the…
    STAT · 4mo agoNegative↗ source
  • FDA finds low levels of PFAS in most U.S. baby formulas, says supply remains largely safe
    The FDA recently tested 312 infant formula samples from 16 brands and released its findings. The agency detected five types of PFAS, with PFOS appearing in about half of the samples, but 95% of th…
    STAT · 4mo agoRegulatoryNeutral↗ 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
  • Opinion: The psychedelic revolution is leaving behind people of color
    Psychedelics’ potential as a form of treatment is virtually unmatched. But their promise faces both scientific uncertainty and thorny political questions.
    STAT · 4mo ago↗ source
  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: OxyContin maker Purdue Pharma set to dissolve after judge approves its criminal sentence
    At the hearing, the judge heard from mothers who lost sons to overdose, a teenager born into withdrawal, and people who spent years dealing with addiction treatment.
    STAT · 4mo ago↗ source