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  • Yarrow goes public while Otsuka receives FDA approval for new ADHD medication
    Yarrow Bioscience completed a merger that took the company public and will now trade under its own ticker. The firm is developing an anti-TSHR antibody aimed at treating Graves’ disease and the ass…
    Endpoints · 5d agoApprovalPositive↗ source
  • RA Capital backs Oak Hill Bio's Nasdaq debut via $175 million SPAC merger
    RA Capital announced that its SPAC, Research Alliance Corporation III, will merge with Oak Hill Bio, creating a new Nasdaq-listed rare-disease company. The combined entity will start with $175 mil…
    Fierce Biotech · 5d agoDealPositive↗ source
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Nephrology239
  • Virginia judge orders FDA to revisit Biden-era mifepristone restrictions
    A federal judge in Virginia has ruled that the FDA must reexamine certain restrictions on the abortion medication mifepristone that were put in place during the previous administration. The judge…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Fujifilm Biotech CEO warns CDMOs must expand services ahead of looming patent cliff
    Fujifilm Biotechnologies CEO Lars Petersen said drugmakers are gearing up for a looming biopharma patent cliff in 2026, a situation that could pressure revenue streams as key patents expire. He wa…
    Endpoints · 5d agoNeutral↗ source
  • PhRMA pushes back as prescription drug spending continues to rise, according to STAT+ newsletter
    STAT+ Health Care Inc. newsletter author Bob Herman reports on the growing concern that prescription drug spending is rising despite industry attempts to downplay it. The piece appears in the July…
    STAT · 5d agoNegative↗ source
  • FDA questions efficacy of Capricor's Duchenne muscular dystrophy cell therapy ahead of advisory committee
    FDA reviewers have raised concerns about the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy as the agency prepares for an advisory committee meeting. The agency said it could n…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 5d agoPositive readoutNegative↗ source
  • MapLight's schizophrenia drug fails primary endpoint in Phase 2, sending stock down over 60%
    MapLight Therapeutics saw its shares tumble more than 60% after a mid‑stage trial showed that its once‑daily schizophrenia candidate did not meet the primary efficacy endpoint, even though the over…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 5d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 5d agoNeutral↗ source
  • FDA advisory panel lifts restrictions on six wellness peptides
    The FDA's advisory committee concluded its two-day meeting by voting to remove the existing limits on six widely used health and wellness peptides. Committee members said the vote overrode earlier…
    Endpoints · 5d agoRegulatoryPositive↗ source
  • MapLight’s schizophrenia drug misses primary endpoint in Phase 2, shares tumble over 60%
    MapLight Therapeutics reported results from a mid‑stage Phase 2 trial of its experimental schizophrenia therapy. The study evaluated a once‑daily dosing regimen and failed to meet the predefined p…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • Sarepta Therapeutics appoints Michael Severino, former Tessera CEO, as new chief executive
    Sarepta Therapeutics announced that Michael Severino will become its chief executive, effective Tuesday. Severino previously led Tessera Therapeutics. He replaces Doug Ingram, who said he will ret…
    STAT · 5d agoNeutral↗ source
  • STAT+: RA Capital backs upstart rival to Ultragenyx and Ionis in rare brain disease
    Oak Hill Bio, a new company backed by RA Capital and other investors, will take on Ultragenyx and Ionis in developing an Angelman syndrome medicine.
    STAT · 5d agoDealNeutral↗ source
  • Argenx to pick up autoimmune biotech Forte Biosciences for $2.2B
    Argenx will spend $2.2 billion to buy Forte Biosciences and its anti-CD122 monoclonal antibody that’s under investigation for autoimmune diseases. The Belgian-Dutch pharma said Monday it will pay $…
    Endpoints · 5d agoDealNeutral↗ source
  • STAT+: Argenx to buy Forte Biosciences for $2.2B
    Argenx plans to buy Forte Biosciences for $2.2 billion, expanding its pipeline of drugs that could treat multiple autoimmune diseases.
    STAT · 5d agoDealNeutral↗ source
  • Argenx acquires Forte for $2.2B to get hands on phase 2-stage vitiligo drug
    Argenx is spending $2.2 billion to absorb Forte Biosciences for its phase 2-stage vitiligo and celiac disease drug.
    Fierce Biotech · 5d agoDealNeutral↗ source
  • Labcorp unveils direct-to-consumer genetic health panel covering 163 genes and 100+ conditions
    Labcorp announced the launch of a new direct-to-consumer test called the Marker by Labcorp Genetic Health Panel. The panel examines 163 genes to assess risk for more than 100 hereditary conditions…
    Fierce Biotech · 5d agoPositive↗ source
  • STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more
    An FDA panel recommended that compounding pharmacies be allowed to make two more peptides, a step toward RFK Jr.'s goal to make them more available
    STAT · 5d agoRegulatoryNeutral↗ source
  • STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
    Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
    STAT · 5d agoRegulatoryNeutral↗ source
  • 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 · 5d 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 · 5d agoRegulatoryNeutral↗ source
  • [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 · 5d 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 · 5d 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 · 5d agoRegulatoryNeutral↗ source