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2,476 stories matching this filter · ← front page

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  • Apnimed announces IPO plans while FDA reviews its sleep-apnea therapy
    Apnimed, a Cambridge, Massachusetts biotech, disclosed that it will pursue an initial public offering on Nasdaq. The move comes as the company’s lead sleep‑apnea candidate is under review by the U…
    Endpoints · 1mo agoDealPositive↗ source
  • Nominee for HHS emergency response role has a history of questioning vaccines
    Sean Kaufman has been selected by the administration to lead the Office of Assistant Secretary for Preparedness and Response, overseeing the nation’s reaction to public health emergencies and disas…
    STAT · 1mo agoRegulatoryNegative↗ source
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  • FDA delays deadline for electric shock device ban
    The Food and Drug Administration has quietly moved the enforcement date for the ban on certain electric shock devices to a later point in time. The agency did not issue a high‑profile announcement,…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA resumes publishing pharma rejection letters, posting 14 new CRLs
    The FDA announced on Friday that it has posted fourteen new complete response letters (CRLs) to pharmaceutical companies on its website. This marks a return to the agency’s regular practice of mak…
    Endpoints · 1mo agoCRLNeutral↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Pfizer promotes Danna Breen to lead obesity discovery, succeeding Kendra Bence
    Pfizer announced that Danna Breen has been promoted to head of its obesity discovery program, according to a LinkedIn post. Breen takes over from Kendra Bence and brings nearly 14 years of experie…
    Endpoints · 1mo agoNeutral↗ source
  • FDA’s drug review center adds over 100 staff in a quarter, first net gain since late 2024
    The FDA’s Center for Drug Evaluation and Research (CDER) reported hiring more than 100 new employees in the most recent quarter. This net increase is the first time the drug center has added more…
    Endpoints · 1mo agoNeutral↗ source
  • Cellular Intelligence hires neurologist to assess Novo Nordisk's Parkinson's stem cell program
    Cellular Intelligence, an AI‑driven biotech, announced it is evaluating Novo Nordisk's Parkinson's stem cell therapy after Novo shut down its cell therapy unit. The company engaged neurologist and…
    Endpoints · 1mo agoDealNeutral↗ source
  • Primary Care Shows Strong Performance Yet Remains Miscast as Health Crisis Solution
    The latest MedPAC report to Congress highlights that primary-care delivery in the United States is performing well by several measures. Nearly all Medicare beneficiaries have a designated primary-c…
    STAT · 1mo agoNeutral↗ source
  • Boys' Club of New York offers after-school program that supports mental health of at-risk boys
    The Boys' Club of New York, a 150-year-old organization, runs three clubhouses serving about 2,500 middle-school boys from disadvantaged backgrounds. The program provides after-school and weekend…
    STAT · 1mo agoPositive↗ source
  • STAT+: How a Boston doctor built a following as a ‘loud and unafraid’ voice in the Trump era
    Jeremy Faust saves lives in the ER and breaks stories with his Inside Medicine newsletter. He’s also testing the bounds of news reporting.
    STAT · 1mo ago↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo ago↗ source
  • Whistleblower takes on health insurance and FDA commissioner candidates
    This week on "The Readout LOUD" podcast: Why does getting family health insurance through a job cost as much as buying a new car? And who might be the new…
    STAT · 1mo ago↗ source
  • ARPA-H bookmarks $160M for custom gene editing treatments. Is it enough?
    After an infant last year was saved from a deadly disease thanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in his DNA, the US government is hoping ...
    Endpoints · 1mo ago↗ source
  • HHS advances plan to pay out Covid-19 vaccine injury claims
    A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that oversees broader vaccine injury payments remains…
    Endpoints · 1mo ago↗ source
  • Roche ends work on tominersen after decade of trials, as well as early-stage Huntington’s asset
    After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after tominersen did no better than placebo in a Phase 2…
    Endpoints · 1mo ago↗ source
  • UK price watchdog recommends against Amgen's Lumakras in lung cancer
    The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institute…
    Endpoints · 1mo ago↗ source
  • FDA criticizes Lundbeck for webpages on migraine treatment Vyepti
    The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages that made allegedly inflated claims regarding the efficacy of its migraine drug. In an untitled letter sent la…
    Endpoints · 1mo ago↗ source
  • GSK ends brain drug alliance with Alector
    Clinical setbacks derailed what was once a potentially $2.2 billion deal that marked GSK's return to neuroscience.
    BioPharma Dive · 1mo ago↗ source
  • FDA quietly stops releasing CRLs
    The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The pause follows a law firm in April
    Endpoints · 1mo ago↗ source
  • Outbreak of diarrhea-causing parasite grows to more than 1,000 cases
    An outbreak of diarrhea-causing parasite has grown to more than 1,000 cases, making it one of the nation’s largest such outbreaks in years.
    STAT · 1mo ago↗ source
  • STAT+: ARPA-H launches $160 million effort to develop custom gene editing drugs
    An ARPA-H program to jump-start custom gene editing treatments was delayed by a change in administrations. Now seven labs will get sizable grants.
    STAT · 1mo ago↗ source
  • The biggest health tech stories of 2026 — so far
    We’re more than halfway through 2026, and it’s been an eventful year. Here are the five biggest developments we noticed in the first six months. Major AI companies are coming for healthcare.
    Endpoints · 1mo ago↗ source
  • STAT+: FDA finalists under review
    Three top contenders to run the FDA are under review by the White House
    STAT · 1mo ago↗ source
  • Ipsen succeeds in migraine trials; Tarsus buys iRenix for $75M upfront
    Plus news on Alchemab, Scipher and Forte. 💉 Ipsen’s Dysport aces Phase 3 migraine trials: The biotech’s injectable neurotoxin met the primary endpoint of reducing monthly migraine days in two ...
    Endpoints · 1mo ago↗ source