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  • UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirements
    UniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Jazz partners with AbCellera on $4 billion deal to develop next-generation T-cell engagers for solid tumors
    Jazz Pharmaceuticals disclosed a collaboration with AbCellera aimed at creating next-generation T-cell-engaging antibodies for solid tumors. Under the agreement Jazz will pay $56 million up front…
    BioPharma Dive · 2mo agoDealPositive↗ source
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fda recalls67
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Pain470
Endocrinology & Metabolism466
Infectious Disease437
  • Westlake-backed Vedana Therapeutics raises $46M to develop anti-PACAP migraine prevention drugs
    Vedana Therapeutics, a new biotech formed out of stealth, announced it has secured $46 million in financing backed by Westlake. The capital will be used to advance its anti-PACAP antibody program a…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Neumora ends development of navacaprant after failed Phase 3 depression trials; EnGene cuts half its workforce
    Neumora Therapeutics announced it will discontinue its kappa opioid receptor antagonist navacaprant after the drug missed its primary endpoints in two Phase 3 studies for major depressive disorder.…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • Eli Lilly to acquire non-opioid pain drug developer 4E Therapeutics, adding MNK inhibitor pipeline
    Eli Lilly announced it will purchase 4E Therapeutics, a biotech focused on non‑opioid pain treatments. The acquisition gives Lilly access to 4E’s experimental pipeline, including MNK inhibitors su…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Edgewise Therapeutics' experimental heart drug meets Phase 2 endpoints in cardiomyopathy trial
    Edgewise Therapeutics reported that its oral candidate EDG-7500 achieved the predefined goals of a Phase 2 study in both obstructive and non‑obstructive hypertrophic cardiomyopathy. The trial demo…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Express Scripts and PCMA file lawsuits to block Tennessee FAIR Rx Act targeting PBM-owned pharmacies
    Express Scripts, a Cigna subsidiary, and the Pharmaceutical Care Management Association have filed separate lawsuits in federal court in Tennessee. The suits challenge the FAIR Rx Act, a law passe…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel
    FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency. The Food and Drug Administration will convene an…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • Medicare rule could bring subcutaneous Keytruda and Opdivo under price negotiations
    A federal rule proposed for 2029 aims to close a loophole that currently shields medicines moving from intravenous to subcutaneous administration from Medicare price negotiations. The Centers for M…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
  • J&J's Talvey plus Darzalex Faspro cuts death risk by up to 53% in relapsed multiple myeloma
    Johnson & Johnson reported that a combination of its immunotherapy Talvey with Darzalex Faspro, with or without Pomalyst, significantly lowered the risk of death in patients with relapsed or refrac…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Lilly reports early positive results for new JAK2 inhibitor in hard-to-treat myelofibrosis
    Lilly has incorporated a JAK2‑targeting drug originally discovered by Ajax Therapeutics after its recent acquisition. The experimental pill is intended for patients with myelofibrosis, a difficult‑…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Celiac disease faces new therapeutic possibilities as companies target underlying inflammation
    Celiac disease affects roughly one in every hundred people worldwide, imposing a daily burden that goes far beyond dietary restrictions. Currently, patients have no approved medicines and must rel…
    BioPharma Dive · 2mo agoPositive↗ source
  • Strategic steps for moving sterile injectables from lab to clinical trials
    The article, sponsored by Vetter, discusses how drug owners of sterile injectable candidates face a key question when a molecule is ready for first‑in‑human studies: how fast can a clinical batch b…
    BioPharma Dive · 2mo agoPositive↗ source
  • Rapport Therapeutics says it is ready to launch its seizure drug independently
    In a recent interview, CEO Abe Ceesay explained that Rapport Therapeutics has assembled an investor syndicate and feels fully prepared to bring its seizure drug to market on its own. Founded in 20…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • J&J reports positive Phase 2/3 results for Imaavy in rare autoimmune anemia, paving way for label expansion
    Johnson & Johnson announced that its drug Imaavy, already approved for myasthenia gravis, produced durable hemoglobin improvements in a Phase 2/3 trial for warm autoimmune hemolytic anemia, a rare…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Takeda’s experimental TYK2 inhibitor zasocitinib outperforms Bristol Myers’ Sotyktu in psoriasis trial
    Takeda announced that its experimental TYK2 inhibitor zasocitinib showed statistical superiority over Bristol Myers Squibb’s approved psoriasis drug Sotyktu in a head‑to‑head study. The 16‑week tr…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Summit Therapeutics cancels $500 million secondary share offering citing market conditions
    Summit Therapeutics announced it would pull a planned $500 million secondary share sale just one day after the announcement, saying market conditions were unfavorable. The offering had been slated…
    BioPharma Dive · 2mo agoDealNegative↗ source
  • Novartis' RNA drug del-brax hits primary endpoint in early-stage FSHD trial
    Novartis reported that its antisense oligonucleotide conjugate, del-brax, achieved the primary biomarker endpoint in a Phase 1/2 study of patients with facioscapulohumeral muscular dystrophy (FSHD)…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Sensorion drops OTOF gene therapy to focus on GJB2-targeted hearing loss candidate after Regeneron approval
    Sensorion said it is ending development of its gene therapy SENS-501 for OTOF related hearing loss after a strategic review. The review concluded that the competitive landscape had changed signific…
    BioPharma Dive · 2mo agoNeutral↗ source
  • AstraZeneca advances obesity pill to Phase 3 after mid-stage trials show ~11% weight loss
    AstraZeneca announced that its experimental oral GLP-1 drug, elecoglipron, will enter an extensive Phase 3 development program following encouraging data from two mid-stage studies in obesity and d…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Parabilis raises record $670 million in biotech IPO, the largest for a venture-backed company
    Parabilis Medicines, a biotech focused on "undruggable" targets, completed an initial public offering that raised $670 million, the biggest amount ever for a venture-backed biotech. The company so…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Sanofi halts Phase 3 trial of riliprubart in CIDP after interim analysis shows unlikely efficacy
    Sanofi announced Wednesday that it is stopping the Phase 3 MOBILIZE study of its experimental anti‑inflammatory drug riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • Ethyreal Bio raises $101M to develop antibody targeting Graves disease and thyroid eye disease
    Ethyreal Bio, a Cambridge-based biotech that has just emerged from stealth mode, announced it has closed a $101 million financing round to advance its lead candidate. The company’s candidate, a mo…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • GSK to acquire Nuvalent for $11 billion, adding two lung-cancer drugs under FDA review
    GSK announced a deal to buy Massachusetts‑based biotech Nuvalent for $11 billion. The acquisition brings two experimental lung‑cancer medicines that are currently under review by the U.S. Food and…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Stealthy biotech Treeline Biosciences to go public via reverse merger with Standard BioTools
    Treeline Biosciences announced a plan to become a public company through a reverse merger with microfluidics firm Standard BioTools. The transaction will give Standard shareholders about 15.5% of…
    BioPharma Dive · 3mo agoDealPositive↗ source