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  • Arbutus and Sanofi launch new patent lawsuits against Pfizer, BioNTech and Moderna over mRNA lipid nanoparticle technology
    Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, accusing them of infringing patents covering the lipid nanoparticle (LNP) technology used to deliver mRNA vaccines. The filin…
    BioPharma Dive · 27d agoRegulatoryNegative↗ source
  • AI-discovered drugs show early promise but face mixed results in clinical trials
    AI is being promoted as a way to cut the cost and time of drug research and development, which can exceed $2.6 billion and take up to 15 years. Only a handful of AI‑identified compounds have enter…
    BioPharma Dive · 27d agoNeutral↗ source
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  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 28d agoNegative↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 27d agoDealPositive↗ source
  • Zealand Pharma appoints former Lilly executive as US marketing head
    Silvia Luque announced on LinkedIn that she will lead US marketing for Zealand Pharma. The appointment follows a 13-year tenure at Eli Lilly, where she held several roles in the company's obesity f…
    Endpoints · 28d agoNeutral↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…
    raps · 28d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…
    raps · 28d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…
    raps · 28d ago↗ source
  • Mirador unveils part of pipeline with drug from Kira to rival Tavneos
    Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached a…
    Endpoints · 28d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    The latest in a prolific streak of buyouts by Lilly is the strongest sign yet that large pharmaceutical companies may finally be embracing a long-dismissed field of research.
    BioPharma Dive · 28d ago↗ source
  • What health system execs are talking about
    Earlier this week, I swung by the American Hospital Association’s Leadership Summit in downtown Denver. When I wasn’t giving out ice cream recommendations, I was trying to get a sense of what hospi…
    Endpoints · 28d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    The Phase 2 data exceeded expectations, lifting company shares as high as nearly $130 apiece and building the case for what may be the first pill specifically approved for female pattern hair loss.
    BioPharma Dive · 28d ago↗ source
  • Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos
    Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan succ…
    Endpoints · 28d ago↗ source
  • Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease
    LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone wit…
    Endpoints · 28d ago↗ source
  • US drug shortages rise for third straight quarter, hurt by lone suppliers
    The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...
    Endpoints · 28d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.
    BioPharma Dive · 28d ago↗ source
  • Updated: Sanofi, Arbutus file separate suits against mRNA vaccine makers over LNP tech patents
    Sanofi and Arbutus are each going to court over alleged violations of their respective mRNA delivery patents, adding to a growing list of companies making similar complaints. The French pharma is s…
    Endpoints · 29d ago↗ source
  • Lilly bets $2.8B upfront on psychedelics in deal to buy AtaiBeckley
    Eli Lilly said on Thursday it will buy psychedelic drug developer AtaiBeckley for $2.8 billion upfront, in a move that further spotlights big pharma’s increasing interest in the space after years o…
    Endpoints · 29d ago↗ source
  • Updated: Merck beats AstraZeneca to approval for first PCSK9 pill
    As in football, so in pharmaceuticals: The English have been beaten. Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-low…
    Endpoints · 29d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 29d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.
    raps · 29d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 29d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 29d ago↗ source
  • FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
    The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasi…
    fda press · 29d ago↗ source
  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face f…
    Endpoints · 29d ago↗ source