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1,811 stories matching this filter · ← front page

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  • FDA’s AI push faces uncertainty after key leaders depart
    The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • GSK launches three-year cost-cutting plan as new CEO targets R&D efficiency
    GSK announced a three-year restructuring program designed to cut costs and sharpen focus on its advanced assets. The plan was presented by CEO Luke Miels, who has been in the role for just over si…
    Endpoints · 1mo agoNeutral↗ source
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  • Oak Hill Bio to go public via SPAC merger, securing $175 million for Angelman syndrome program
    Oak Hill Bio announced it will become a publicly traded company through a merger with the special purpose acquisition company Research Alliance Corporation III. The transaction will provide $75 mi…
    BioSpace · 1mo agoDealPositive↗ source
  • Altimmune's GLP-1/glucagon shot reduces drinking in Phase 2 alcohol use disorder trial
    Altimmune announced results from its mid‑stage Phase 2 RECLAIM trial evaluating pemvidutide, a GLP‑1/glucagon dual agonist, in patients with moderate‑to‑severe alcohol use disorder. The trial comp…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA advisory panel debates allowing compounding pharmacies to produce seven peptides
    The FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Webinar Explores AI-Driven Intelligence Engine for Optimizing Antibody, ADC and Peptide Candidates
    Drug discovery teams are grappling with an ever‑growing volume of data, and converting that data into actionable insight remains a key hurdle. In a recent BioSpace webinar, Patsnap’s Ben Coverdale…
    BioSpace · 1mo agoNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD
    Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
    BioSpace · 1mo agoApprovalPositive↗ source
  • AstraZeneca reports mixed late-stage trial results: Claudin 18.2 ADC shows limited success while Ultomiris fails in rare disease
    AstraZeneca announced that two of its late-stage clinical programs have delivered disappointing outcomes. The company disclosed the data in a statement released on Monday. The trial of the Claudin…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • 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 · 1mo agoApprovalPositive↗ source
  • AstraZeneca says AI has yet to yield clinical candidates but could lower risk in late-stage trials
    AstraZeneca's chief executive Pascal Soriot told reporters that the company's AI‑driven efforts in drug design have not yet produced a candidate that has entered clinical testing. He added that th…
    Endpoints · 1mo agoNeutral↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti‑CD122 antibody program
    Argenx announced a $2.2 billion cash transaction to purchase Forte Biosciences, a biotech focused on autoimmune therapies. The acquisition brings Forte's anti‑CD122 monoclonal antibody, which is c…
    Endpoints · 1mo agoDealPositive↗ source
  • 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 · 1mo 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 · 1mo agoNeutral↗ 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 · 1mo 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 · 1mo agoPositive readoutNegative↗ source
  • FDA says Capricor's DMD cell therapy failed to meet Phase 3 endpoints
    The FDA briefing documents released before an advisory committee meeting state that the Phase 3 trial of Capricor's deramiocel did not achieve its pre-specified primary and secondary efficacy endpo…
    BioSpace · 1mo agoRegulatoryNegative↗ 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie R&D chief Michael Severino as new CEO amid DMD regulatory outlook
    Sarepta Therapeutics announced that Michael Severino, who previously led Tessera Therapeutics and served as AbbVie’s head of research and development, will become the company’s chief executive. Sev…
    BioSpace · 1mo agoPositive↗ 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 · 1mo agoNeutral↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti-CD122 antibody FB102
    Argenx announced it will buy Texas‑based Forte Biosciences in a transaction valued at roughly $2.2 billion. The offer of $77 per share represents an 86 % premium to Forte’s recent average price. T…
    BioSpace · 1mo agoDealPositive↗ source