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1,691 stories matching this filter · ← front page

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  • BridgeBio’s ATTR drug Attruby posts strong Q2 sales surge as Alnylam trims Amvuttra outlook
    BridgeBio Pharma reported that its transthyretin amyloidosis treatment Attruby generated $222.4 million in second‑quarter sales, more than triple the $71.5 million earned in the same period a year…
    BioSpace · 12d agoEarningsPositive↗ source
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 12d agoApprovalPositive↗ source
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Endocrinology & Metabolism395
Infectious Disease373
  • Study finds cancer patients now wait longer for treatment than a decade ago
    A new analysis of more than 2.7 million cancer cases shows that the interval between diagnosis and the start of therapy has grown over the past ten years. The researchers examined records from a na…
    STAT · 12d agoNegative↗ source
  • Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects
    A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients w…
    STAT · 13d agoRegulatoryNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 12d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Definium's LSD pill shows significant anxiety reduction in Phase 3 trial
    Definium Therapeutics announced results of a Phase 3 trial testing its LSD‑based pill DT120 in patients with generalized anxiety disorder. The study enrolled 214 participants who received a single…
    STAT · 12d agoPositive readoutPositive↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 12d agoDealPositive↗ source
  • WHO and DRC move to fast-track Phase 3 Ebola vaccine trial, starting with Merck’s Ervebo
    The World Health Organization and authorities in the Democratic Republic of the Congo are negotiating to speed up the launch of a multi‑armed Phase 3 trial of Ebola vaccines. The effort targets th…
    STAT · 12d agoCRLPositive↗ source
  • Fifth Circuit Court Rules in Favor of Providers on No Surprises Act Arbitration, May Increase Payments
    The U.S. Court of Appeals for the Fifth Circuit issued a decision that sides with health-care providers in a lawsuit over the No Surprises Act. The case stemmed from a 2022 Texas Medical Associati…
    STAT · 12d agoRegulatoryPositive↗ source
  • WHO calls Trump’s vaccine policy order misguided, warns it could increase needle shots and disease risk for children
    WHO Director-General Tedros Adhanom Ghebreyesus and other senior officials criticized a new U.S. executive order that seeks to overhaul the childhood vaccination schedule. The order, signed by Pre…
    STAT · 12d agoRegulatoryNegative↗ source
  • Eli Lilly sues six U.S. entities over illegal retatrutide sales, urges broader crackdown
    Eli Lilly announced legal action against six U.S. entities accused of selling its experimental obesity drug retatrutide on the black market. The lawsuits target compounding pharmacies, medical spa…
    BioSpace · 12d agoRegulatoryNeutral↗ source
  • Lilly sues over black-market retatrutide; Neurocrine's new obesity drug linked to patient deaths
    Eli Lilly has filed six lawsuits against U.S. companies it says are illegally selling black-market versions of its experimental obesity drug retatrutide. The company alleges the defendants are dist…
    STAT · 12d agoRegulatoryNegative↗ source
  • Aardvark Therapeutics abandons phase 3 trials after workforce cuts and FDA hold
    Aardvark Therapeutics announced it is walking away from its recently terminated phase 3 trials, stating there are no plans to resume them as originally designed. The decision follows a reduction i…
    Fierce Biotech · 12d agoRegulatoryNegative↗ source
  • Samsung gets FDA clearance for Galaxy Buds hearing-aid features
    Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests. The hearing tes…
    Fierce Biotech · 13d agoApprovalPositive↗ source
  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 13d agoPositive↗ source
  • White House rolls out treatment-first addiction toolkit emphasizing faith-based care and abstinence
    The Trump administration introduced a new framework for addressing addiction and homelessness, called a "treatment-first" toolkit. The toolkit prioritizes medical treatment and faith-based program…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Hardie’s Fresh Foods recalls 5‑lb pepper jalapenos over potential Salmonella contamination
    Dairyland Produce, operating as Hardie’s Fresh Foods in Houston and Dallas, announced a recall of its 5‑pound pepper jalapeno product due to possible Salmonella contamination. The recall affects j…
    fda recalls · 12d agoRegulatoryNegative↗ source
  • Commure's AI-driven referral program draws complaints of financial losses from health-care customers
    Commure, a Silicon Valley startup valued at $7 billion, builds AI tools aimed at automating health‑care administrative work such as scheduling, billing and prior‑authorization. According to intern…
    STAT · 13d agoNegative↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 13d agoNegative↗ source
  • FDA releases proposed commitment letter detailing changes to GDUFA IV program
    The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
    raps · 13d agoRegulatoryNeutral↗ source
  • Vaping and cannabis use hit record highs among U.S. young adults in 2025, survey finds
    A new national survey by the University of Michigan shows vaping and cannabis use among U.S. young adults reached record levels in 2025. Past‑30‑day nicotine vape use rose to 19%, more than triple…
    STAT · 12d agoNegative↗ source
  • Postpartum psychiatry remains inadequately understood, case of Lindsay Clancy highlights gaps
    The opinion piece, authored by a neuroscience professor at Tufts, an obstetrics‑psychiatry specialist at NewYork‑Presbyterian and Weill Cornell, and a psychiatry researcher at the University of Vir…
    STAT · 12d agoNegative↗ source
  • North Carolina biopharma job postings jump 26% as seven companies announce dozens of openings
    Bio NC’s hotbed is seeing a surge in employment opportunities, with BioSpace data showing a 26% year‑over‑year rise in job postings in July and an upward trend since November. Seven companies are…
    BioSpace · 12d agoPositive↗ source
  • Renowned autoimmune researcher Georg Schett co-founds biotech to develop antibody therapies
    Georg Schett, a German scientist noted for pioneering CAR‑T approaches in autoimmune disease, is now launching a new biotech venture. The startup, which has not yet been named in the report, will…
    STAT · 12d agoDealPositive↗ source