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  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 29d agoNegative↗ source
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 29d agoDealPositive↗ source
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  • MDCalc introduces quality-rating system for over 800 clinical calculators used by doctors
    MDCalc, a health‑technology company, announced a new quality‑rating system that will evaluate the more than 800 clinical calculators doctors rely on for decisions such as kidney function, birth out…
    STAT · 29d agoPositive↗ source
  • GSK halts camlipixant development after mixed Phase 3 results curb blockbuster hopes
    GSK announced it is stopping work on camlipixant, a P2X3 receptor antagonist it bought when acquiring Bellus Health in 2023, after the drug produced mixed results in two Phase 3 chronic cough trial…
    Fierce Biotech · 29d agoNegative readoutNegative↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 29d agoDealPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 29d agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 29d agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 29d agoRegulatoryNegative↗ source
  • Fierce Biotech flags five cities poised to become next biotech powerhouses
    Fierce Biotech’s latest special report identifies five cities that could emerge as major biotech hubs. The podcast episode of “The Top Line” highlights Boston, San Francisco, Beijing, Seattle and C…
    Fierce Biotech · 29d agoPositive↗ source
  • CDC links Taco Bell lettuce in five states to cyclospora outbreak
    Federal health officials have identified shredded iceberg lettuce from Mexico served at Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio and West Virginia as the source of a widespread cy…
    STAT · 29d agoRegulatoryNegative↗ source
  • GSK discontinues its chronic cough therapy amid uncertain future
    GSK has announced that it is ending development of its chronic cough treatment. The decision marks the conclusion of the program that had been under investigation for several years. The article do…
    STAT · 29d agoNegative↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 29d agoDealPositive↗ source
  • Sonothera touts ultrasound gene-delivery platform for Duchenne, but experts remain skeptical
    Sonothera, a California startup, says its ultrasound‑based technology can deliver therapeutic genes into cells, a method it believes could treat Duchenne muscular dystrophy and other genetic disord…
    STAT · 29d agoNeutral↗ source
  • Opinion: MAHA pushes psychiatric deprescribing agenda, reshaping mental-health language
    Sunny Patel, an associate professor of psychiatry and pediatrics at Georgetown University, critiques the Mental Health Advocacy (MAHA) movement in a recent opinion piece. He notes her background wi…
    STAT · 29d agoNegative↗ source
  • Ichnos Glenmark Innovation appoints Mariana Cota Stirner as chief medical officer
    Ichnos Glenmark Innovation announced the appointment of a new chief medical officer. Mariana Cota Stirner will assume the role, bringing experience from her recent position as fractional chief med…
    STAT · 29d agoNeutral↗ source
  • Canadian wildfires drive NYC asthma ER visits up 31% as heat wave intensifies haze
    Recent Canadian wildfires have produced massive smoke plumes that have drifted into the United States, degrading air quality across many cities. In New York City, emergency department visits for a…
    STAT · 28d agoNeutral↗ source
  • Zealand Pharma appoints former Lilly executive as US marketing head
    Silvia Luque announced on LinkedIn that she will lead US marketing for Zealand Pharma. The appointment follows a 13-year tenure at Eli Lilly, where she held several roles in the company's obesity f…
    Endpoints · 29d agoNeutral↗ source
  • Trump administration moves to restore LGBTQ+ youth counseling on 988 line amid concerns over trans identity exclusion
    Specialized counseling services for LGBTQ+ youth are slated to return to the 988 Suicide & Crisis Lifeline by the end of the year, according to a recent confirmation from the Trump administration.…
    STAT · 29d agoRegulatoryNegative↗ source
  • FDA approves Merck’s first oral PCSK9 inhibitor, marking a first for the drug class
    The U.S. Food and Drug Administration has granted approval to Merck for its oral PCSK9 inhibitor, the first drug of this type to receive such clearance. The approval represents a milestone because…
    STAT · 1mo agoApprovalPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion
    Eli Lilly announced it will acquire AtaiBeckley, a biotech focused on psychedelic therapies for mental health, for an upfront cash payment of $2.8 billion. The purchase adds a new dimension to Lil…
    STAT · 1mo agoDealPositive↗ source
  • Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZeneca
    Merck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management. The approval comes…
    Endpoints · 1mo agoApprovalPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo agoApprovalPositive↗ source
  • UnitedHealth beats Q2 forecasts but warns rising insurance costs will strain employers
    UnitedHealth Group reported second-quarter results that exceeded analysts' expectations, lifting its shares modestly. Despite the upbeat earnings, executives highlighted that medical expenses for…
    STAT · 1mo agoEarningsNegative↗ source
  • US drug shortages climb for third consecutive quarter, many rely on single suppliers
    The latest data show that the count of medicines in shortage across the United States increased again in the most recent quarter, marking the third straight period of growth. Analysts note that ne…
    Endpoints · 1mo agoNegative↗ source
  • Takeda's zasocitinib clears scalp psoriasis in 75% of patients in phase 3 data
    Takeda released updated results from its two phase 3 trials of the oral TYK2 inhibitor zasocitinib, enrolling a total of 1,801 patients with moderate-to-severe plaque psoriasis. The data showed th…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source