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  • Hinge receives FDA clearance for new migraine device
    Hinge announced that its migraine treatment device has received clearance from the U.S. Food and Drug Administration. The clearance allows the company to market the device in the United States and…
    STAT · 6mo agoApprovalPositive↗ 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
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  • 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
  • Trump withdraws Casey Means as surgeon general nominee, names radiologist Nicole Saphier
    The Trump administration has withdrawn its nomination of Casey Means to serve as the next surgeon general. Means had been backed by the Make America Healthy Again movement, which sees the decision…
    STAT · 6mo agoNegative↗ source
  • New data link rising wildfire smoke to greater health risks, while FDA confirms infant formula safety
    Recent analyses show that smoke from increasingly frequent wildfires is contributing to higher levels of air pollution, which researchers say is linked to a range of adverse health outcomes. The U…
    STAT · 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
  • Data show international medical graduates are not displacing U.S. doctors in 2026 residency match
    The opinion piece examines a social‑media narrative that International Medical Graduates (IMGs) are taking residency slots away from U.S. medical graduates. The authors cite the 2026 Main Residenc…
    STAT · 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
  • Chiesi to acquire KalVista for $1.9 billion, adding oral hereditary angioedema drug Ekterly to its rare-disease portfolio
    Chiesi Group announced it will purchase KalVista Pharmaceuticals for $1.9 billion, gaining ownership of Ekterly, an oral on‑demand treatment for hereditary angioedema (HAE). Ekterly received FDA a…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
    The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review. AstraZeneca and Amgen have l…
    BioPharma Dive · 6mo agoRegulatoryNeutral↗ source
  • Chiesi to acquire KalVista for $1.9 billion, adding hereditary angioedema pill to rare-disease portfolio
    Italian pharmaceutical group Chiesi announced it will purchase KalVista Therapeutics for $1.9 billion. The transaction values KalVista at $27 per share, a 40 percent premium to its last closing pri…
    STAT · 6mo agoDealPositive↗ source
  • GSK CEO warns possible team reorganization if upcoming Phase 3 readouts fall short
    GSK's chief executive Luke Miels told analysts during the first‑quarter earnings call that the company has several pivotal Phase 3 trials slated for this year. He said that if those late‑stage rea…
    Endpoints · 6mo agoNeutral↗ source
  • Supreme Court hints skinny labeling may remain viable for generic drugs
    At a hearing, Supreme Court justices heard arguments about skinny labeling, a practice used by generic manufacturers to seek approval for a subset of a brand drug's indications. The justices did n…
    STAT · 6mo agoRegulatoryPositive↗ source
  • AbbVie's Skyrizi sales growth raises investor worries about J&J competition
    During AbbVie's first-quarter earnings call, analysts focused on the company's immunology franchise and asked how it would defend Skyrizi against emerging competition from Johnson & Johnson. The c…
    Endpoints · 6mo agoEarningsNegative↗ source
  • FDA schedules first oncology advisory panel in nine months, will review AstraZeneca candidates
    The FDA announced it will hold an oncology advisory committee meeting roughly nine months from now. The meeting will focus on evaluating a pair of investigational drugs from AstraZeneca, though de…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • Health AI discourse shifts from hype to practical discussion, says STAT newsletter
    Brittany Trang, a health‑tech reporter at STAT, reflects on how the conversation around artificial intelligence in healthcare is changing. In her AI Prognosis newsletter she notes that the industry…
    STAT · 6mo agoPositive↗ source
  • Bristol Myers Squibb faces identity crisis as CEO Chris Boerner enters make-or-break year
    Bristol Myers Squibb is at a strategic crossroads as its chief executive, Chris Boerner, approaches the midway point of his tenure. After roughly two and a half years in the role, Boerner has over…
    Endpoints · 6mo agoNegative↗ source
  • Biogen seeks early-stage pipeline deals after $5.6 billion Apellis acquisition
    Biogen announced it has earmarked $5.6 billion to acquire Apellis Pharmaceuticals, a move completed earlier this month. Despite the large transaction, the company says it will continue to explore…
    Endpoints · 6mo agoDealPositive↗ source
  • AstraZeneca lifts UK investment pause, pledges £300 million for new office expansion
    AstraZeneca announced on Wednesday that it is ending its pause on UK investment and will allocate £300 million to complete construction of a new office facility. The funding is intended to expand t…
    Endpoints · 6mo agoDealPositive↗ source
  • Chiesi to acquire KalVista Pharmaceuticals for $1.9 billion in cash deal
    Italian pharma Chiesi announced it will purchase commercial biotech KalVista Pharmaceuticals. The transaction is valued at about $1.9 billion, with Chiesi paying $27 per share in cash. The acquis…
    Endpoints · 6mo agoDealPositive↗ source
  • AstraZeneca halts several mid- and late-stage trials after efficacy setbacks
    AstraZeneca announced it has stopped a number of mid- and late-stage clinical trials in its pipeline over recent months. The decision follows disappointing efficacy results in those studies, limit…
    Endpoints · 6mo agoNegative↗ source
  • Teva nabs experimental Tourette drug in $700M Emalex buyout
    A Jefferies analyst argued the deal — Teva’s largest in a decade — “makes sense” given the synergies between Emalex and the pharmaceutical giant’s neurology business.
    BioPharma Dive · 6mo agoDealNeutral↗ source
  • FDA moves to speed trials by reviewing AstraZeneca and Amgen data in real time, seeks public input on pilot program
    The U.S. Food and Drug Administration announced a new initiative aimed at making clinical trials faster and more efficient. As a first step, the agency will begin reviewing trial data in real time…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Health Secretary Kennedy moves to reverse FDA ban on peptide compounding, raising safety concerns
    Health Secretary Robert F. Kennedy Jr. is pushing to overturn a 2023 FDA rule that stopped compounding of certain peptides, a move that could reopen a market for products such as BPC-157 and GHK-Cu…
    STAT · 6mo agoRegulatoryNegative↗ source
  • FDA reports most U.S. infant formulas contain only trace or undetectable levels of heavy metals and other contaminants
    The Food and Drug Administration examined 312 samples drawn from 16 major infant‑formula brands, looking for residues of heavy metals, pesticides, PFAS and phthalates. Across the board the agency…
    STAT · 6mo agoRegulatoryPositive↗ source