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  • 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
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  • 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
  • OpenLoop Health says it can launch a virtual GLP-1 prescribing service in 24 hours
    OpenLoop Health says it can set up a telehealth operation that can prescribe GLP-1 medicines within a day. The company provides the medical‑group infrastructure that powers multiple virtual care p…
    Endpoints · 2mo agoNeutral↗ 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
  • CMS proposes rule to close Medicare negotiation loophole for biologics
    CMS announced a proposed policy change that would clarify how the Centers for Medicare & Medicaid Services groups products for price negotiations under the Inflation Reduction Act. The rule target…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA says it will maintain Makary’s focus on clinical trials, rare diseases and China despite leadership exits
    The Food and Drug Administration announced that, even after the recent resignations of Commissioner Marty Makary and the heads of its drug and biologics centers, it will keep pursuing the policy ag…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Takeda releases additional Phase 3 data to bolster its orexin program amid new competition
    Takeda announced new results from its two Phase 3 trials of an orexin‑targeting therapy. The data are intended to demonstrate the drug’s efficacy and safety, reinforcing Takeda’s claim of market‑l…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Elicio Therapeutics’ KRAS pancreatic cancer vaccine fails in Phase 2, stock drops sharply
    Elicio Therapeutics reported that its KRAS‑targeted vaccine for pancreatic cancer did not improve patient outcomes in a mid‑stage (Phase 2) trial. The study results were released in a company state…
    Endpoints · 2mo agoNegative readoutNegative↗ source