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  • A trend that isn’t fading, ultra-processed baby foods
    An FDA advisory panel serves some peptide wins, a measles record, and more health news from Morning Rounds
    STAT · 1d agoRegulatoryNeutral↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
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  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • From confidence to capital: Positioning biotech for the next growth cycle
    How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • Opinion: How midwives like me can help fight medical misinformation
    “I have come to believe that changing a mind is rarely the point. Planting a seed is,” writes nurse-midwife Mara Evans.
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: As some medical schools embrace RFK Jr.’s nutrition push, they deftly sidestep MAHA priorities
    Even as some medical schools heed health secretary Robert F. Kennedy Jr.’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Opinion: E-bikes, e-scooters are a burgeoning pediatric public health emergency
    “Emergency departments across America report dramatic increases in serious injuries from e-bikes and e-scooters,” write CHOP’s J. Todd R. Lawrence and Madison A. Kesler.
    STAT · 1d agoRegulatoryNeutral↗ source
  • Denmark’s foundation‑fueled biotech boom redraws the Nordic map
    Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • ‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug
    A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.
    Fierce Biotech · 1d agoNeutral↗ source
  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 1d agoNeutral↗ source
  • MapLight’s schizophrenia drug disappoints once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 1d agoNeutral↗ source
  • Legend CEO Ying Huang resigns; Carvykti chief named interim leader
    Legend Biotech, the developer of the blockbuster cancer therapy Carvykti, is in the market for a new CEO. Ying Huang stepped down Friday after serving as CEO since November 2020, Legend announced in a
    Endpoints · 1d agoNeutral↗ source
  • Sarepta turns to Michael Severino as CEO, looking to move past recent turmoil
    Sarepta Therapeutics has found its new CEO as it seeks to recover from a calamitous past year. Michael Severino will replace the company’s longtime leader Doug Ingram on Tuesday. Severino joins fro…
    Endpoints · 1d agoNeutral↗ source
  • AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings
    AstraZeneca’s use of AI in drug design and development has not yet yielded any clinical-stage candidates, CEO Pascal Soriot said Monday, but he added it could be useful in boosting the success of l…
    Endpoints · 1d agoNeutral↗ source
  • Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
    AstraZeneca said Monday that a key late-stage trial of its Claudin 18.2-targeting ADC in stomach cancer had succeeded, albeit with a caveat — but another Phase 3 trial of Ultomiris yielded subpar r…
    Endpoints · 1d agoNeutral↗ source
  • Schrödinger debuts AI agent Bunsen to use its physics software
    Three years ago, Schrödinger CEO Ramy Farid ruffled some feathers by pushing back on the AI fever of the moment. He said AI hype was at "dangerous" and "insane" levels, warning there ...
    Endpoints · 1d agoNeutral↗ source
  • Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears
    Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.
    Fierce Biotech · 1d agoNeutral↗ source
  • MapLight shares sink on mixed phase 2 schizophrenia readout
    MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
    Fierce Biotech · 1d agoNeutral↗ source
  • Legend Biotech CEO abruptly steps down without permanent replacement
    In a sudden leadership shift, Legend Biotech announced that its CEO, Ying Huang, Ph.D., resigned on Friday, with no permanent replacement yet named.
    Fierce Biotech · 1d agoNeutral↗ source
  • Labcorp launches DTC ‘Genetic Health Panel’ to seek out multiple diseases
    Labcorp is launching the Marker by Labcorp Genetic Health Panel, a new direct-to-consumer genetic testing tool that analyzes 163 genes to determine patients’ risk of over 100 hereditary health cond…
    Fierce Biotech · 1d ago↗ source
  • Recon: WHO releases first interim list of medical device authorities; AstraZeneca using AI to hedge late-stage risks
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Researchers find similar drug development to reimbursement timelines for major markets
    Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.
    raps · 1d ago↗ source
  • EMA says it takes ultimate responsibility for protecting online meeting registration, survey information
    The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies, o…
    raps · 1d ago↗ source
  • FDA finalizes three guidances to broaden cancer clinical trial eligibility
    The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials.…
    raps · 1d ago↗ source