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  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • cAMPfield Therapeutics raises $180 million to develop oral IBD drug prifemilast
    cAMPfield Therapeutics, a California biotech, announced a $180 million Series A financing to advance its oral anti‑inflammatory candidate for inflammatory bowel disease. The investigational drug,…
    BioPharma Dive · 2mo agoDealPositive↗ source
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  • Novo Nordisk invests $380M to expand manufacturing in Czech Republic and China, while Cellares raises $50M Series D
    Novo Nordisk announced a significant investment to broaden its manufacturing footprint in both China and the Czech Republic. In the Czech Republic, the company is allocating roughly $380 million t…
    Endpoints · 2mo agoDealPositive↗ source
  • Medicare $2,000 out-of-pocket cap boosts use of high-cost drugs, study shows
    A recent study published in JAMA Health Forum examined how the Inflation Reduction Act’s $2,000 annual out-of-pocket limit for Medicare beneficiaries affected drug consumption. The analysis found…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • FDA advisory panel unanimously backs Moderna’s flu vaccine
    The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Moderna’s seasonal influenza vaccine. The vote overturns earlier hesitations from previous agen…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • U.S. Treasury Considers New Screening Rules for Investments in Chinese Biotech
    Treasury Department officials are reviewing possible measures to screen U.S. capital flowing into Chinese biotechnology firms, according to multiple sources familiar with the discussions. The revi…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Biogen to acquire RayThera in up to $1 billion deal for immunology pipeline
    Biogen announced it will acquire RayThera, a startup founded in 2023, in a deal valued at up to $1 billion. The acquisition gives Biogen access to RayThera’s immunology pipeline, which includes th…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Pfizer CFO to leave in August as GSK secures approval for urinary-tract infection drug
    Pfizer announced that its chief financial officer, Dave Denton, will step down in August, ending his tenure at the company. GSK reported that it has received regulatory approval for a new treatmen…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Novocure's electric field therapy fails Phase 3 glioblastoma trial, not extending patient survival
    Novocure announced on Thursday that its electric fields device, used together with standard chemoradiation, did not improve overall survival for patients with glioblastoma in a Phase 3 trial. The…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Moderna appoints Ester Banque as chief commercial officer and expands Stephen Hoge's responsibilities
    Moderna announced a leadership reshuffle as it readies for upcoming product launches. The company named Ester Banque, who previously led U.S. operations at animal health firm Zoetis, as its new ch…
    Endpoints · 2mo agoNeutral↗ source
  • Eli Lilly's TuneLab AI platform reaches 100 members and integrates Chai's models
    Eli Lilly has built TuneLab, an AI initiative that gives biotech companies free access to a range of artificial‑intelligence tools to support drug discovery and development. The program recently a…
    Endpoints · 2mo agoPositive↗ source
  • F2G and Shionogi report positive Phase 3 results for antifungal candidate olorofim
    F2G and Shionogi announced that their joint antifungal candidate, olorofim, met the primary endpoints in a Phase 3 trial. The data were released Thursday morning and showed the drug performed compa…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Cardiovascular biotech Kardigan raises $400M in IPO, fourth 2026 $400M+ offering
    Kardigan, a cardiovascular drug startup, priced a $400 million initial public offering on Wednesday, adding to a recent surge in large biotech offerings. The company becomes the fourth biotech in…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Kardigan secures $400 million IPO to fund three clinical-stage cardiovascular candidates
    Kardigan, a New Jersey biotech focused on heart disease, announced it raised $400 million in a Nasdaq initial public offering. The capital will be directed toward advancing three clinical-stage dr…
    Endpoints · 2mo agoDealPositive↗ source
  • Biogen to acquire San Diego biotech RayThera in up to $1 billion deal
    Biogen announced it will acquire RayThera, a San Diego-based biotech, in a transaction valued at up to $1 billion. The agreement specifies that most of the payment will be made through milestone-b…
    Endpoints · 2mo agoDealPositive↗ source
  • RA Capital, Forbion and Sanofi Ventures back Korean eye-drug startup
    RA Capital, Forbion and Sanofi Ventures are reported to be providing financing for a new eye-drug company that is developing its product in Korea. The investment follows a growing pattern where la…
    Endpoints · 2mo agoDealNeutral↗ source
  • Innoviva revives Lyndra's long-acting oral drug platform
    Innoviva, a healthcare asset and royalties holding firm, announced it is bringing back Lyndra's long-acting oral drug delivery platform. The technology, which previously attracted more than $380 mi…
    Endpoints · 2mo agoPositive↗ source
  • 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
  • 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