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  • Eli Lilly to acquire cancer cell therapy startup Kelonia Therapeutics for $3.2 billion
    Eli Lilly announced it will buy privately held Kelonia Therapeutics, a biotech focused on cell therapies for cancer and autoimmune diseases, in a deal valued at $3.2 billion. Kelonia has operated…
    STAT · 4mo agoDealPositive↗ source
  • European regulators recommend Sanofi's MS drug tolebrutinib for approval after US rejection
    European Medicines Agency officials issued a positive recommendation for tolebrutinib, an experimental multiple sclerosis therapy from Sanofi, after the U.S. FDA rejected the drug earlier this year…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
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  • Sanofi’s tolebrutinib receives EU CHMP endorsement for specific multiple sclerosis patients despite US FDA setback
    Sanofi's BTK inhibitor tolebrutinib is moving toward approval in the European Union for a subset of multiple sclerosis patients. The Committee for Medicinal Products for Human Use (CHMP) of the Eu…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • FDA to fast-track review of three psychedelic therapies for depression and PTSD
    The FDA announced it will accelerate the review of psychedelic drugs from three companies as part of a broader initiative to increase access to mental-health treatments. Compass Pathways will rece…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Utah medical board urges halt to AI-driven prescription renewal pilot
    Utah launched a pilot program that partners with AI startup Doctronic to let a chatbot conduct clinical evaluations and automatically renew prescriptions for roughly 200 medications, without direct…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Avalyn Pharma targets $182M IPO as WHO prequalifies Novartis malaria drug
    Avalyn Pharma announced plans for an initial public offering that could raise about $182 million in net proceeds. The company is developing inhaled formulations of drugs already approved for pulmon…
    Endpoints · 4mo agoDealNeutral↗ source
  • Novartis withdraws EU filing for Pluvicto label expansion into early-stage prostate cancer
    Novartis announced it has pulled its application to the European Medicines Agency to extend the label of its radioligand therapy Pluvicto for use in earlier stages of prostate cancer. The move com…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Lilly shares slide as Foundayo prescriptions lag expectations, while Novo's Wegovy gains momentum
    Eli Lilly's stock fell nearly 5% after the latest weekly prescription count for its obesity drug Foundayo missed analysts' expectations. IQVIA data showed U.S. prescriptions for Foundayo reached 3…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Trump announces drug pricing deal with Regeneron, completing White House's 17-deal target
    President Trump announced a drug‑pricing agreement with Regeneron Pharmaceuticals, marking the final deal in the administration's goal of securing 17 pricing arrangements. The agreement is intende…
    STAT · 4mo agoDealPositive↗ source
  • Sanofi's multiple sclerosis drug, previously rejected by FDA, receives positive recommendation from European regulators
    Sanofi's multiple sclerosis drug, which the U.S. FDA turned down late last year, has now been reviewed by European authorities. The European regulators issued a positive recommendation today, sugg…
    STAT · 4mo agoRegulatoryPositive↗ source
  • White House signs executive order to expand access to psychedelic therapies
    President Trump signed an executive order aimed at increasing the availability of psychedelic drug treatments. The order was announced alongside podcaster Joe Rogan, who said he had messaged the pr…
    STAT · 4mo agoRegulatoryPositive↗ source
  • FDA grants fast-track vouchers to three psychedelic firms
    The FDA announced it has issued fast-track development vouchers to three companies working on psychedelic therapies. The recipients are R&DCompass, Transcend, and the Usona Institute. The vouchers…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • UC Berkeley spinout explores gene-editing approach to GLP-1 based weight-loss therapy
    UC Berkeley researchers have launched a startup that plans to use jumping genes to deliver GLP-1 gene therapy for obesity treatment. The approach seeks to create a long-lasting source of the hormon…
    Endpoints · 4mo agoNeutral↗ source
  • Guest-edited journal issues face mass retractions over compromised peer review
    A recent retraction by the British Medical Journal’s publishing group removed almost an entire special issue of the Journal of Medical Genetics that focused on cancer immunotherapies. The journal…
    STAT · 4mo agoNegative↗ source
  • International childhood vaccine campaign expands, newsletter reports
    The latest Morning Rounds newsletter notes that a global campaign to increase childhood vaccination rates is gaining momentum. The piece highlights the growing reach of the effort without providing…
    STAT · 4mo agoNeutral↗ source
  • Daiichi Sankyo delays release of annual results, shares fall
    Daiichi Sankyo announced it will postpone the reporting of its annual results, saying more time is needed to finalize the numbers. The company had planned to unveil the financials for its fiscal y…
    Endpoints · 4mo agoNegative↗ source
  • Pfizer strategy chief Andrew Baum departs, stays on as senior advisor; Helus Pharma appoints new CEO after two months
    Andrew Baum, formerly chief strategy and innovation officer at Pfizer, has left that role. He will continue to work with the company as a senior strategic advisor to CEO Albert Bourla. Meanwhile,…
    Endpoints · 4mo agoNeutral↗ source
  • Tenpoint Therapeutics appoints Stephen Lane as chief medical officer
    STAT+ columnist Ed Silverman highlights recent personnel moves in the pharma sector. This week’s note focuses on a new senior appointment at Tenpoint Therapeutics. The company has hired Stephen La…
    STAT · 4mo agoNeutral↗ source
  • Local news shutdown threatens health reporting, but Pittsburgh Post-Gazette finds a lifeline
    The decline of local news outlets is eroding the coverage of health and science topics that communities rely on for accurate information. In early January, the Pittsburgh Post-Gazette, Western Pen…
    STAT · 4mo agoNegative↗ source
  • Veteran neonatal nurse practitioner begins medical school at 69 and prepares for family-medicine residency at 72
    Dawn Zuidgeest-Craft, a 69-year-old, is about to begin medical school after a career spanning more than four decades as a neonatal nurse practitioner. She aims to complete her training and start a…
    STAT · 4mo agoPositive↗ source
  • Regeneron secures first FDA approval for gene therapy treating rare inherited hearing loss
    Regeneron announced that the U.S. Food and Drug Administration has approved its gene-based treatment Otarmeni, marking the first approval of a therapy for inherited hearing loss. The therapy is de…
    Endpoints · 4mo agoApprovalPositive↗ source
  • FDA approves Regeneron’s Otarmeni gene therapy for rare inherited hearing loss
    The FDA has approved Otarmeni, a gene therapy from Regeneron, marking the first therapy cleared under the agency’s national priority voucher program and will be provided to eligible patients at no…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • AbbVie to invest $1.4 billion in new 185-acre manufacturing campus in Durham, North Carolina
    AbbVie announced a $1.4 billion investment to build a large manufacturing campus in Durham, North Carolina. The 185-acre site will focus on producing small-volume parenteral medicines such as vial…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Sanofi beats Q1 sales forecasts, driven by strong Dupixent demand
    Sanofi reported first‑quarter results that exceeded Wall Street expectations, with net sales rising 6.2% to €10.5 billion (about $12.3 billion).\n\nThe growth was led by Dupixent, the anti‑inflamma…
    BioPharma Dive · 4mo agoEarningsPositive↗ source
  • Novo Nordisk's GLP-1 pill shows blood-sugar reduction in teens with type 2 diabetes
    Novo Nordisk reported results from a study evaluating its oral GLP-1 therapy, Rybelsus, in adolescents with type 2 diabetes. The trial enrolled participants aged 10-17 who took the pill for roughl…
    Endpoints · 4mo agoPositive readoutPositive↗ source