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  • Lundbeck advances PACAP-targeting migraine drug after mid-stage trial shows reduction in migraine days
    Lundbeck reported new data from a mid-stage study of its experimental migraine prevention therapy, bocunebart, which targets the PACAP protein involved in headache pathways. The trial enrolled hun…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Roche's daily incretin injection shows promise in Phase 2 trial for type 1 diabetes
    Roche reported that its experimental daily incretin injection achieved positive results in a Phase 2 study involving patients with type 1 diabetes. The study, the first mid-stage trial of a GLP-1…
    Endpoints · 3mo agoPositive readoutPositive↗ source
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  • CDC warns Ebola could swell to 20,000 cases in Central Africa without rapid containment
    The U.S. Centers for Disease Control and Prevention released a new analysis indicating that the Ebola outbreak in Central Africa could expand to as many as 20,000 cases if infected individuals are…
    STAT · 3mo agoNegative↗ source
  • HHS reclassifies 8,000 staff under Schedule F, easing firing rules and raising political pressure
    An executive order issued in late June reclassified roughly 8,000 employees of the Department of Health and Human Services. The change moves them into a “Schedule F” category that removes many civi…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Supreme Court rules generic Vascepa copy does not infringe patents, boosting skinny-label pathway
    The U.S. Supreme Court issued a decision that Hikma Pharmaceuticals’ generic version of Amarin’s heart drug Vascepa does not infringe the brand’s patents. The ruling clarified that the generic make…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Innovent Biologics reports Phase 3 success for stomach cancer ADC, now under priority review in China
    Innovent Biologics announced that its antibody‑drug conjugate (ADC) candidate has met the primary endpoint in a Phase 3 trial for advanced stomach cancer. The positive outcome has placed the produ…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Fulcrum Therapeutics cuts workforce, retaining only nine employees as layoffs hit 48 staff
    Fulcrum Therapeutics announced a dramatic reduction in its staff, letting go of 48 of its 57 full‑time employees. The move leaves the company with just nine remaining workers, effectively turning i…
    Endpoints · 3mo agoLayoffsNegative↗ source
  • Analysts warn that PD-1/VEGF bispecific drugs may be better suited for liver cancer than lung cancer
    Many drugmakers have poured billions into PD-1/VEGF bispecific antibodies after ivonescimab beat Keytruda in a 2024 lung‑cancer trial, sparking a wave of deals and development programs. A recent C…
    BioPharma Dive · 3mo agoNeutral↗ source
  • HHS Office of Human Research Protections faces staff shortages, jeopardizing participant safety oversight
    In 2021 the Office of Human Research Protections (OHRP) received a report of a participant suicide during a depression and mobility study at the New York State Psychiatric Institute. The incident p…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Biotech lobby groups in Washington push to keep Chinese low-cost drug pipeline open amid rising anti-China proposals
    Washington biotech lobby groups are working to ensure a steady flow of affordable medicines that originate from Chinese manufacturers. These groups have become aware that they are encountering voc…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Industry and rare disease groups call for more transparency in FDA voucher pilot
    The pharmaceutical industry and rare‑disease advocacy groups have voiced concerns about the Commissioner's National Priority Voucher pilot program. Stakeholders say the program lacks transparency…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • ADA conference preview spotlights newer GLP-1 drugs, research funding cuts and a protest
    Elizabeth Cooney reports from the American Diabetes Association annual meeting in New Orleans, introducing the first of three STAT "ADA in 30 Seconds" newsletters. She notes the warm weather outsid…
    STAT · 3mo agoNeutral↗ source
  • House Appropriations Committee urges FDA to accelerate IND approvals for clinical trials
    The House Appropriations Committee issued a directive to the Food and Drug Administration, calling for reforms to speed up the Investigational New Drug (IND) sign-off process for new clinical trial…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • US shifts Ebola treatment for exposed Americans to overseas facilities, sparking concerns over care access
    In an opinion piece, infectious‑disease physician Krutika Kuppalli reflects on her experience responding to the West Africa Ebola outbreak and the expectations that the United States would bring il…
    STAT · 3mo agoRegulatoryNegative↗ source
  • NIH senior adviser promotes MAHA strategy at ADA conference amid skeptical audience
    At the American Diabetes Association meeting in New Orleans, Richard Woychik, a senior adviser to NIH Director Jay Bhattacharya, opened his remarks by endorsing the Make America Healthy Again (MAHA…
    STAT · 3mo agoNeutral↗ source
  • RevMed’s experimental pancreatic cancer drug available via expanded access as FDA voucher program faces potential changes
    RevMed's experimental pancreatic cancer therapy daraxonrasib has not received FDA approval yet, but the company is offering it through an expanded access (compassionate use) program. Access to the…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Texas attorney general probes energy drink safety as federal research ethics office shrinks dramatically
    The Texas attorney general has opened an inquiry into the safety and marketing claims of popular energy drinks, seeking to determine whether they pose health risks or violate state consumer protect…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • FDA faces Roche blackmail claim, launches mifepristone safety study and reviews voucher program pause request
    Roche has publicly accused the United States of blackmail in a dispute that surfaced in recent FDA discussions. The company’s allegation adds tension to ongoing regulatory dialogues. The Food and…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Uli Stilz joins Flagship while Revolution Medicines adds Alex Hoffman as commercial lead
    On June 5, 2026, biotech veteran Uli Stilz announced his new position at Flagship, marking a notable personnel shift in the industry. Stilz has spent much of the year traveling internationally, in…
    Endpoints · 3mo agoNeutral↗ source
  • Infinimmune appoints Srikanth Pendyala as new chief medical officer
    Infinimmune announced the addition of Srikanth Pendyala to its leadership team as chief medical officer. Pendyala comes to the role after serving in the same capacity at Stealth NewCo and Endeavor…
    STAT · 3mo agoPositive↗ source
  • Physician’s personal emergency highlights safety concerns in universal health care systems
    Nisha Narayanan, a clinical assistant professor of pediatrics who splits her practice between New York City and Edinburgh, reflects on how moving abroad reshaped her views on health care. Three we…
    STAT · 3mo agoNeutral↗ source
  • ADC Therapeutics shares plunge as Phase 3 trial of Zynlonta shows high death rate despite efficacy gain
    ADC Therapeutics reported Phase 3 data for Zynlonta combined with rituximab in a hard-to-treat blood cancer. The trial met its primary endpoint by extending progression-free survival versus standar…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Novo Nordisk Indiana plant faces FDA re-inspection after hair found in drugs and roof leaks threaten sterility
    Novo Nordisk's fill‑finish facility in Bloomington, Indiana underwent a follow‑up FDA inspection in April. The agency reported mammalian hair in finished drug containers and identified water leaks…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Otsuka presents new data to bolster full approval bid for Voyxact in IgA nephropathy
    Otsuka Pharmaceutical announced that new clinical evidence has been generated for its monoclonal antibody Voyxact, aimed at treating IgA nephropathy, a chronic autoimmune kidney disease. The data,…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Supreme Court rules generic maker Hikma does not infringe Amarin patents, easing skinny-label lawsuits
    The U.S. Supreme Court issued a unanimous decision that Hikma Pharmaceuticals did not violate patents owned by Amarin. The high court overturned a lower court ruling that had favored the brand name…
    STAT · 3mo agoRegulatoryPositive↗ source