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416 stories matching this filter · ← front page

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  • Abbott Q2 led by strong device, diagnostic sales as it boosts profit forecast
    Abbott turned in a stronger-than-expected second quarter, allaying market concerns that subsidy cuts to the Affordable Care Act by the Trump administration would hurt medtech firms.
    Fierce Biotech · 14d ago↗ source
  • GSK axes key cough drug candidate after phase 3 data end blockbuster hopes
    GSK has ended development of camlipixant in chronic cough after delivering mixed phase 3 data, dealing a major blow to a potential blockbuster that analysts saw as the key 2026 catalyst for the dru…
    Fierce Biotech · 14d ago↗ source
  • Dimerix snaps up Mission’s stalled, phase 2-ready kidney disease candidate in $292M deal
    Dimerix has bought an acute kidney injury drug from Mission Therapeutics, paying $5 million upfront and committing up to $287 million in milestones for the phase 2-ready asset.
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Vaccines516
Endocrinology & Metabolism290
Ophthalmology255
Infectious Disease253
Nephrology238
Fierce Biotech · 14d ago↗ source
  • Biotronik Neuro snaps up spinal cord stimulation portfolio from Soin Neuroscience for next-gen pain project
    Biotronik Neuro has acquired a portfolio of spinal cord stimulation patents from the Ohio-based medical device company Soin Neuroscience as the pair look to create “a next-generation spinal cord st…
    Fierce Biotech · 14d ago↗ 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 · 14d 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 · 14d 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 · 14d ago↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 15d ago↗ source
  • Chutes & Ladders—Cue lines up new CMO and research head
    Cue Biopharma is tapping in a new chief medical officer and head of R&D in Dominic Borie, M.D., Ph.D., a physician-scientist with over two decades of industry experience.
    Fierce Biotech · 15d ago↗ source
  • FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
    The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…
    BioSpace · 15d ago↗ source
  • Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
    With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
    BioSpace · 15d ago↗ source
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    BioSpace · 15d ago↗ source
  • Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immuno
    Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is lookin…
    BioSpace · 15d ago↗ source
  • The future of pain relief: Exploring opioid alternatives
    In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has…
    BioSpace · 15d ago↗ source
  • J&J sees Spravato sales surge as psychedelic competitors loom
    Psychedelics, chiefly Compass Pathways' COMP360, are unlikely to make an immediate dent in the sales of Johnson & Johnson’s depression drug Spravato, H.C. Wainwright’s Patrick Trucchio told BioSpace.
    BioSpace · 15d ago↗ source
  • Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update
    Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
    Fierce Biotech · 15d ago↗ source
  • Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial
    A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.
    Fierce Biotech · 15d ago↗ source
  • Spurred by deep cuts and M&A activity, H1 layoffs could oust 14,000+ in biopharma
    Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac.
    BioSpace · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 16d ago↗ source
  • Nobel Laureate Jennifer Doudna enters AI protein design arena
    Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered pro…
    Fierce Biotech · 16d ago↗ source