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  • Trump administration proposes overhaul of federal grant rules, sparking researcher concerns
    The White House released a more than 400-page proposal that would rewrite the core regulation governing all federal grants. The administration says the changes are meant to curb waste and increase…
    STAT · 3mo agoRegulatoryNegative↗ source
  • White House reviews FDA's new prescription drug user fee agreement for 2028-2032
    The White House is currently reviewing a recently negotiated agreement between the FDA and the biopharma industry that determines the level of prescription-drug user fees for the period 2028 throug…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
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  • Eli Lilly stops disclosing Phase 1 pipeline, making early-stage projects invisible in earnings decks
    Eli Lilly has become more opaque as its size grows, choosing to stop public disclosure of its early-stage research efforts. The shift was noted earlier this year when the company removed Phase 1 pr…
    Endpoints · 3mo agoNegative↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • AstraZeneca explores options after anselamimab fails Phase 3, while Imfinzi and Tremfya receive label expansions
    AstraZeneca announced that its experimental monoclonal antibody anselamimab failed to meet the primary endpoint in two Phase 3 trials for a specific patient group. The company said it will explore…
    Endpoints · 3mo agoNegative readoutNeutral↗ source
  • Agios halts development of tebapivat for low-risk MDS after disappointing Phase 2b data
    Agios Pharmaceuticals announced it will discontinue development of its pyruvate kinase activator tebapivat for patients with low-risk myelodysplastic syndromes (MDS). The decision follows the relea…
    Endpoints · 3mo agoNegative↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • Former FDA official says leadership turnover won’t derail push for faster US drug trials
    The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, h…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • US says Ebola patients will be evacuated to Europe, not treated in America, as outbreak grows
    The World Health Organization is reviewing which vaccines could help curb the expanding Ebola outbreak in Africa. The U.S. government announced it will no longer bring Americans infected with Ebol…
    STAT · 3mo agoRegulatoryNegative↗ source
  • XPRIZE Healthspan launches $101 million competition to test anti-aging therapies in older adults
    Jamie Justice, former Wake Forest professor, now leads XPRIZE Healthspan, a global contest aimed at finding treatments that can restore muscle, cognition and immune function in older people. The c…
    STAT · 3mo agoPositive↗ source
  • Replimune seeks third FDA approval attempt, Pfizer signs China deal, panel backs updated Covid vaccine
    Replimune is pursuing a third attempt to secure FDA approval for its investigational therapy, after two prior submissions did not succeed. Pfizer has entered into a new agreement to expand its pre…
    STAT · 3mo agoNeutral↗ source
  • Allogene announces CEO David Chang will step down
    Allogene Therapeutics disclosed that its chief executive, David Chang, will be leaving the company. The firm indicated that a succession plan is in place, though it did not provide a specific timel…
    STAT · 3mo agoNeutral↗ source
  • Massachusetts sues UnitedHealth over alleged Medicaid fraud targeting seniors
    Massachusetts Attorney General Andrea Joy Campbell filed a lawsuit against UnitedHealth Group's UnitedHealthcare subsidiary, alleging the insurer deliberately over‑coded health conditions of low‑in…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Allogene CEO David Chang to step down after eight years; former Esperion chief joins Phlow
    Longtime Allogene chief executive David Chang announced he will leave the role at the end of June, concluding an eight‑year tenure leading the cell‑therapy developer. The company said a successor…
    Endpoints · 3mo agoNeutral↗ source
  • Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections
    Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussion…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Kenyan court halts U.S. plan for Ebola quarantine facility for Americans
    A Nairobi High Court on Friday ordered a stop to a U.S. proposal to build a quarantine center in Kenya for Americans who might have been exposed to a rare Ebola strain circulating in northeastern C…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Weight-loss doctor warns against unproven GLP-1 microdosing for cosmetic use
    Dr. Jody Dushay, a Harvard‑affiliated weight‑loss specialist, says patients are asking about tiny doses of GLP‑1 drugs for cosmetic slimming. She notes there is no scientific definition of “microd…
    STAT · 3mo agoNegative↗ source
  • GC Therapeutics appoints former BlueRock executive Stefan Irion as chief scientific officer
    GC Therapeutics announced that Stefan Irion has joined the company as its new chief scientific officer. Irion previously served in the same capacity at BlueRock Therapeutics. Irion brings experien…
    STAT · 3mo agoNeutral↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • GSK reports strong Phase 3 results for Ionis-licensed chronic hepatitis B therapy
    GSK disclosed data from two late‑stage trials of a chronic hepatitis B treatment it licensed from Ionis Pharmaceuticals. The studies evaluated the drug’s efficacy and safety in patients with chroni…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly's obesity drugs Foundayo and Zepbound added to CVS Caremark formulary
    Eli Lilly announced that its two flagship obesity treatments, the oral agent Foundayo and the injectable Zepbound, will be listed on CVS Caremark's drug formularies. The inclusion comes as the GLP…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • CVS adds Lilly’s Foundayo and Zepbound to formularies, leveling GLP-1 market with Novo
    CVS Caremark announced it will place Eli Lilly’s new oral GLP-1 drug Foundayo on its formulary starting June 1 and will restore the injectable Zepbound as a preferred option from Oct 1. The change…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • AbbVie receives FDA approval for ultra-rare blood cancer ADC acquired from ImmunoGen
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for an antibody-drug conjugate targeting an ultra-rare, aggressive form of blood cancer. The therapy was obtained t…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Signos secures $20 million to advance GLP-1-focused wearable platform amid broader wearables interest
    The article notes that two wearable‑related developments are being discussed, and both involve GLP‑1 therapies. Signos announced it has raised $20 million to fund its approach that combines wearab…
    Endpoints · 3mo agoDealPositive↗ source
  • ICON audit reveals $65.3M and $92.7M revenue overstatements; Secretome and Psilera announce cash raises
    ICON completed an internal audit that confirmed its reported revenue had been overstated. The audit quantified the overstatement at $65.3 million for 2023, representing about 0.8% of that year's t…
    Endpoints · 3mo agoRegulatoryNeutral↗ source