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486 stories matching this filter · ← front page

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  • 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 · 11d 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.
    Fierce Biotech · 11d 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…
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Fierce Biotech · 11d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    <p>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…
    raps · 11d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    <p>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.…
    raps · 11d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    <p>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…
    raps · 11d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    <figure><div><img src="https://imgproxy.divecdn.com/tzaRDX3CbhReY4UgPVj2iCgN5MzQ9V_AQf0Jo1lvCvY/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy05OTEzMjk1ODQuanBn.…
    BioPharma Dive · 11d 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 · 11d 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 · 11d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    <figure><div><img src="https://imgproxy.divecdn.com/1t2735bLf2pFiAc5XoslOwKIkl5O8g-p7viDbIw1C94/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA2NDE3NzE0LmpwZ…
    BioPharma Dive · 11d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    <figure><div><img src="https://imgproxy.divecdn.com/fBH5yVoS6G-IUV5sTGP2zy7wuLAX60VYZCXs0QOEVRo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TY3JlZW5zaG90XzIwMjItMDctMjRfMS40M…
    BioPharma Dive · 11d 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 · 11d 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.<br>
    Fierce Biotech · 11d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 12d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    <p>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.</p>
    raps · 12d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    <p>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…
    raps · 12d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    <p>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 a…
    raps · 12d ago↗ source
  • Celcuity gains FDA approval for closely watched breast cancer drug
    <figure><div><img src="https://imgproxy.divecdn.com/f5a4VRDXQg-SwH2yBDKHbtLeyVHpX8cemnSbe-t-6xU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNDk4X0F5Q…
    BioPharma Dive · 12d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    <figure><div><img src="https://imgproxy.divecdn.com/lM3CYabLlmazQYt-COfrxYzxdsO20VnU3PS1vfCq2lE/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjEwOTMxMjkxXzEua…
    BioPharma Dive · 12d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    <figure><div><img src="https://imgproxy.divecdn.com/Z8dYUynyAGfRpaERds4uqJPo8FGtQPXgqxIr2sImOmo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDUxMTE2NzE0LmpwZ…
    BioPharma Dive · 12d 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 · 12d ago↗ source
  • Why early de-risking is redefining the path to IND
    Lonza explains why early de-risking has become a strategic imperative for biotech teams working to reach IND with confidence.
    Fierce Biotech · 12d ago↗ source
  • Understanding Agentic AI in Clinical Development
    Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but becaus…
    Fierce Biotech · 12d ago↗ source
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 12d ago↗ source
  • Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs
    When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for th…
    Fierce Biotech · 12d ago↗ source