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2,058 stories matching this filter · ← front page

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  • Industry eyes revenue potential of next‑generation peptide drugs beyond GLP‑1
    The article notes that just a few years ago analysts were busy estimating the market size for GLP‑1 based weight‑loss medicines. Today the conversation has shifted toward the commercial possibilit…
    Endpoints · 2mo agoNeutral↗ source
  • UK waitlist for Novo Nordisk’s Wegovy reaches 30,000 a week, tripling after approval
    Novo Nordisk’s weight‑loss injection Wegovy has been approved in the United Kingdom. Within a week of the green light, a major online pharmacy reported that its waiting list surged to roughly 30,00…
    Endpoints · 2mo agoApprovalPositive↗ source
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fda recalls67
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Infectious Disease439
  • Jazz Pharmaceuticals partners with AbCellera on T-cell engager program targeting GI cancers, deal up to $4.1 billion
    Jazz Pharmaceuticals announced a new collaboration with Canadian antibody company AbCellera to develop T-cell engager therapies aimed at gastrointestinal cancers. The agreement could be worth as m…
    Endpoints · 2mo agoDealPositive↗ source
  • Spot Bio raises $40M to begin mRNA therapy trials for Duchenne muscular dystrophy
    Spot Bio, a biotech startup operating in California and China, has started preclinical testing of a genetic medicine aimed at restoring the missing protein dystrophin in patients with Duchenne musc…
    Endpoints · 2mo agoDealPositive↗ source
  • FDA signals new window for companies with recent complete response letters after commissioner’s exit
    After FDA Commissioner Marty Makary left, the agency indicated it will reconsider drugs that received complete response letters in the past year. The move offers sponsors a chance to resubmit thei…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • FDA issues warning letters to 25 telehealth firms over misleading compounded GLP-1 marketing
    The U.S. Food and Drug Administration has sent warning letters to 25 telehealth companies. The letters cite concerns about how the firms promote compounded GLP-1 drugs used for weight loss. The ag…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • 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
  • Hackers claim to have stolen Novo Nordisk AI models and drug manufacturing recipes, demand $25M ransom
    Novo Nordisk disclosed that a hacker group says it has obtained the company's proprietary AI models and manufacturing recipes for its drugs. The group alleges the data is for sale and has demanded…
    Endpoints · 2mo agoNegative↗ source
  • FDA reverses earlier stance, grants uniQure accelerated approval pathway for Huntington's gene therapy
    On June 17, 2026, the U.S. Food and Drug Administration issued a second reversal, allowing biotech company uniQure to pursue an accelerated approval pathway for its gene therapy targeting Huntingto…
    Endpoints · 2mo agoRegulatoryPositive↗ 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
  • 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
  • Triveni Bio secures $65M Series C as second eczema candidate enters clinical trials
    Triveni Bio announced a $65 million Series C financing round aimed at supporting its ongoing development programs. The round was co‑led by Ascenta Capital and Janus Henderson Investors, with parti…
    Endpoints · 2mo agoDealPositive↗ source
  • Migraine biotech Vedana Therapeutics raises $46 million Series A to advance preclinical pipeline
    Vedana Therapeutics, a new biotech focused on migraine, has announced its emergence from stealth mode after securing a Series A financing round. The company raised $46 million from investors, whic…
    Endpoints · 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
  • FDA gives modest backing to Moderna’s flu vaccine, noting efficacy questions but no major concerns
    The FDA released briefing documents ahead of an advisory committee meeting on Moderna’s seasonal influenza vaccine. The agency’s assessment was described as tepid, highlighting some questions abou…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA approves Colorado plan to import lower-cost drugs from Canada
    The U.S. Food and Drug Administration issued a letter confirming that Colorado may move forward with a pilot program to bring prescription medicines from Canada. The proposal aims to lower drug co…
    Endpoints · 2mo agoRegulatoryPositive↗ 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
  • Edgewise Therapeutics moves heart disease drug into Phase 3 after updated Phase 2 data
    Edgewise Therapeutics announced on June 16, 2026 that it will advance its investigational therapy for a genetic heart disease into a registrational Phase 3 trial. The decision follows an updated a…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Eli Lilly acquires another pain biotech, its 11th deal this year, as FDA eyes decision on once‑weekly PrEP pill
    Eli Lilly announced the purchase of an Austin, Texas‑based pain biotechnology company, marking the 11th acquisition the Indianapolis‑based firm has completed in 2026. The deal expands Lilly's portf…
    Endpoints · 2mo agoDealNeutral↗ source
  • Health groups accuse HHS of rushing reinstatement of CDC vaccine advisory panel
    A coalition of health organizations has publicly charged the U.S. Department of Health and Human Services with attempting to accelerate the return of the CDC's Advisory Committee on Immunization Pr…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • UCSF spinout Kopra Bio secures $9.1M to advance virus therapy for glioblastoma in China
    Kopra Bio, a biotechnology company spun out of the University of California, San Francisco, announced it has raised $9.1 million in financing. The capital will be used to move its experimental viru…
    Endpoints · 2mo agoDealPositive↗ source
  • Be Bio halts hemophilia B cell-editing therapy trial
    Be Bio announced that it has terminated its clinical study of a hemophilia B therapy that used gene-editing of a patient’s own cells. The termination was recorded in a federal clinical-trials regi…
    Endpoints · 2mo agoNegative readoutNegative↗ source