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  • J&J offers $5.5 billion settlement to resolve talc lawsuits
    Johnson & Johnson has put forward a settlement proposal of $5.5 billion to end the litigation over its talc products. The proposal follows more than a decade of legal battles and three unsuccessfu…
    Endpoints · 4d agoDealNeutral↗ source
  • FDA updates guidance for generic makers of top GLP-1 weight-loss drugs
    The FDA has released a revised draft guidance aimed at companies that want to develop generic versions of leading weight-loss medications. The update focuses on products such as Eli Lilly's Zepbou…
    Endpoints · 4d agoRegulatoryNeutral↗ source
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  • Oak Hill Bio to merge with RA Capital SPAC as InnoCare’s TYK2 candidate reports positive Phase 3 results
    Oak Hill Bio, a biotech focused on Angelman syndrome, announced it will combine with RA Capital’s special purpose acquisition company, Research Alliance Corporation III. The transaction will give O…
    Endpoints · 4d agoDealPositive↗ source
  • FDA staff say Replimune's melanoma trial fails to demonstrate efficacy
    FDA staff reviewing Replimune's pivotal melanoma study concluded that the trial design did not provide sufficient evidence that the RP1 therapy works. The assessment was issued ahead of a schedule…
    Endpoints · 4d agoRegulatoryNegative↗ source
  • Alnylam shares tumble 30% even as biotech sector rallies
    Alnylam's stock fell about 30% on July 28, 2026, even though the broader biotech market is experiencing a resurgence. The market rebound follows years of a bearish environment, with increased merg…
    Endpoints · 4d agoNegative↗ source
  • Mirae secures $5.4 million to convert patient chatbot messages into clinical data
    Mirae, a health‑tech startup, announced it has closed a financing round that brought in $5.4 million. The capital will be used to develop its chatbot platform that encourages patients to describe…
    Endpoints · 4d agoDealPositive↗ source
  • Claris Bio secures $118 million to launch pivotal eye-drop trials next year
    Claris Bio announced a financing round that raised $118 million to move its investigational eye‑drop therapy forward. The capital will fund two pivotal Phase 3 studies slated to start next year, f…
    Endpoints · 4d agoDealPositive↗ 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 · 4d agoNeutral↗ 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 · 4d 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 · 4d 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 · 4d 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 · 4d agoRegulatoryNeutral↗ 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 · 4d agoRegulatoryNeutral↗ 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 · 5d agoApprovalPositive↗ 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 · 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
  • 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'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
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 5d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 5d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 5d agoRegulatoryNeutral↗ 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
  • 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
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 5d agoNeutral↗ source