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  • NodThera rebrands as Rezera and targets Phase 3 trial in 2027
    NodThera, a biotech focused on the NLRP3 inflammatory pathway for about ten years, announced a strategic shift. The company said it will rebrand itself as Rezera and is preparing to launch a pivot…
    Endpoints · 4h agoNeutral↗ source
  • AI tools struggle to improve emergency room workflow, study finds
    The article notes that CEOs of leading AI firms have promised dramatic health benefits, but real‑world testing in emergency departments tells a different story. At Brigham and Women’s Hospital, th…
    STAT · 7h agoNegative↗ source
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Evommune's MRGPRX2 antagonist fails second Phase 2b trial in atopic dermatitis
Evommune reported that its experimental small-molecule antagonist of the MRGPRX2 receptor did not meet its primary endpoints in a Phase 2b study in patients with atopic dermatitis. The study, cond…
Endpoints · 7h agoNegative readoutNegative↗ source
  • FDA makes acting CBER and CDER heads permanent, signaling leadership continuity
    FDA promoted Michael Davis and Karim Mikhail from acting to permanent heads of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The ap…
    BioSpace · 3h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · just nowLayoffsNegative↗ source
  • Career setbacks offer data points, not definitive verdicts, says executive coach
    Angela Justice, an executive coach, describes how a sudden layoff can feel like a verdict but is really just a data point. She warns that people often turn the specific lesson from a setback into…
    BioSpace · 8h agoNeutral↗ source
  • FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders
    After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said.
    BioPharma Dive · 30m ago↗ source
  • STAT+: Can AI fix the emergency room?
    AI can't change the ER's problems, which exemplify health care's bigger problems, writes Brittany Trang in this week's AI Prognosis.
    STAT · 35m ago↗ source
  • Luma locks down 15-year, $410M fund for life science investments
    Luma Group announced the final close of its inaugural life sciences venture capital fund totaling $410 million.
    Fierce Biotech · 5h ago↗ source
  • Google-backed Encoded gains $275M to advance Dravet drug, scale genetic med manufacturing
    Neuro-focused Encoded Therapeutics has bagged a $275 million series F round to support its Dravet syndrome asset and scale up its internal manufacturing capabilities.
    Fierce Biotech · 5h ago↗ source
  • Kura creates Lilly-backed spinout armed with $50M to advance next-gen diabetes therapy
    Kura Oncology has spun out a biotech armed with $50 million in fresh funding to take forward a next-generation diabetes treatment.
    Fierce Biotech · 6h ago↗ source
  • Labcorp snaps up MLM Medical Labs to boost laboratory footprint
    Medtech and testing giant Labcorp has bought out MLM Medical Labs to help grow its geographic footprint for laboratory services.
    Fierce Biotech · 13h ago↗ source
  • Inhibrx’s OX40 agonist plus Keytruda shows 48% response rate, beating Keytruda alone in head and neck cancer Phase 2
    Inhibrx reported results from its Phase 2 HexAgon trial evaluating INBRX-106, an OX40 receptor agonist, combined with Merck’s Keytruda in patients with treatment‑naïve, PD‑L1‑positive metastatic or…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • FDA approves Revolution Medicines’ pancreatic cancer drug Rasonque, but patients face delayed access
    The U.S. Food and Drug Administration has granted approval to Rasonque, a new therapy for pancreatic cancer developed by Revolution Medicines. The decision follows clinical data that showed the dru…
    STAT · 1d agoApprovalNeutral↗ source
  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • AstraZeneca’s experimental COPD drug tozorakimab cuts flare-ups by 30% in Phase 3 trials
    In two Phase 3 studies, AstraZeneca’s injectable COPD candidate tozorakimab reduced the rate of disease exacerbations by roughly 30%, according to data released on Tuesday. The trials measured flar…
    STAT · 1d agoPositive readoutPositive↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 1d agoCRLNegative↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 20h agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca's new breast cancer therapy
    The U.S. Food and Drug Administration has granted approval for AstraZeneca's latest breast cancer drug, expanding treatment options for patients with the disease. The approval follows a review of…
    STAT · 1d agoApprovalPositive↗ source
  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 1d agoPositive readoutPositive↗ source
  • Novartis' DM1 drug del-desiran misses primary endpoint in Phase 3 HARBOR trial
    Novartis announced that its experimental therapy del-desiran did not improve muscle function in a pivotal Phase 3 study for myotonic dystrophy type 1 (DM1). The trial, called HARBOR, evaluated the…
    STAT · 1d agoNegative readoutNegative↗ source
  • Amgen reports positive lung cancer trial results for Imdelltra combined with checkpoint inhibitor
    Amgen announced that its T-cell engager candidate Imdelltra, when used together with a checkpoint inhibitor, showed a clinical benefit in patients with advanced lung cancer. The trial data indicat…
    Endpoints · 21h agoPositive readoutPositive↗ source
  • FDA finalizes Krazati withdrawal while Wegovy trial shows positive results in children 6-12
    Regulators have officially completed the withdrawal of Krazati, a drug that was being developed for second-line treatment of colorectal cancer. The FDA’s final action ends the product’s availabilit…
    Endpoints · 1d agoRegulatoryNeutral↗ source