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48 stories matching this filter · ← front page

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  • EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial
    EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet a…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
  • EyePoint’s Phase 3 eye drug falls short of Eylea, stock tumbles 70%
    EyePoint reported that its experimental treatment for wet age-related macular degeneration did not meet the efficacy endpoints in a Phase 3 trial when compared with the current standard, Eylea. The…
    Endpoints · 2d agoNegative readoutNegative↗ source
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fda recalls47
fda medwatch36
fda press28
885
Psychiatry & CNS708
Ophthalmology416
Pain371
Endocrinology & Metabolism370
Infectious Disease346
  • Oma's Pride recalls one lot of 6 lb Woof Complete canine chicken food after Salmonella contamination
    Oma's Pride of Avon, Connecticut, announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing revealed Salmonella contamination.…
    fda recalls · 2d agoCRLNeutral↗ source
  • Oma's Pride recalls one lot of Woof Complete Canine Chicken Recipe due to possible Salmonella contamination
    Oma's Pride of Avon, Connecticut announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing identified Salmonella contamination.…
    fda recalls · 7d agoRegulatoryNegative↗ source
  • Tarsus to acquire eye-drug startup Alkeus in up to $800 million deal
    Tarsus Pharmaceuticals announced Thursday that it will buy Alkeus Pharmaceuticals for up to $800 million, consisting of $270 million in cash and $180 million in stock. The agreement also provides…
    BioPharma Dive · 13d agoDealPositive↗ source
  • Tarsus Pharma to spend $450M upfront acquiring Alkeus to expand its ophthalmology pipeline
    Tarsus Pharmaceuticals announced it will acquire Alkeus Pharmaceuticals, a Phase 3 biotech focused on a Stargardt disease drug, for an upfront payment of $450 million. The deal is intended to broad…
    Endpoints · 13d agoDealPositive↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • Claris Bio raises $118M Series B and appoints new CEO to advance eye-drug for limbal stem cell deficiency
    Claris Bio, a New Jersey biotechnology company, announced a $118 million Series B financing round co-led by Samsara BioCapital and Catalio Capital Management, with participation from Sofinnova Inve…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Claris Bio secures $118 million to launch pivotal eye-drop trials next year
    Claris Bio announced a financing round that raised $118 million to move its investigational eye‑drop therapy forward. The capital will fund two pivotal Phase 3 studies slated to start next year, f…
    Endpoints · 22d agoDealPositive↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 22d agoDealNeutral↗ source
  • Yarrow goes public while Otsuka receives FDA approval for new ADHD medication
    Yarrow Bioscience completed a merger that took the company public and will now trade under its own ticker. The firm is developing an anti-TSHR antibody aimed at treating Graves’ disease and the ass…
    Endpoints · 23d agoApprovalPositive↗ source
  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 23d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 23d agoNeutral↗ source
  • Biogen's tau-targeting Alzheimer's drug shows cognitive slowing in mid-stage trial
    Biogen reported results from its mid-stage "Celia" trial testing the experimental tau-targeting antibody BIIB080 in patients with early Alzheimer's disease. The study compared three dose levels of…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Lyora Therapeutics launches to revive early-stage genetic eye disease programs from Editas and Biogen
    Lyora Therapeutics announced its formation as a new genetic‑medicine company focused on eye diseases. The firm will take over several early‑stage programs that were previously in the pipelines of E…
    Endpoints · 1mo agoPositive↗ source
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Oberland pours up to $400M into MeiraGTx eye gene therapies
    The funding deal is a vote of confidence in the sales potential of multiple prospects in late-stage development — one of which MeiraGTx recently reacquired from J&J.
    BioPharma Dive · 1mo ago↗ source
  • Roche KRAS drug succeeds in head-to-head lung cancer study
    The Phase 3 trial compared Roche’s divarasib with treatments sold by Amgen and Bristol Myers in patients with non-small cell lung cancer.
    BioPharma Dive · 1mo ago↗ source
  • Viridian may have edge over Amgen in eye drug showdown, analysts argue
    The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.
    BioPharma Dive · 1mo ago↗ source
  • These biotechs just landed big fundraising hauls. Here’s what they pitched to investors.
    Biotechs aimed at eye diseases, autoimmune conditions and longevity medicine have pulled in some of the largest capital raises so far this year.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea
    The trend continues in which big-name venture investors band together to back new companies with an experimental medicine developed by another biotech. RA Capital and Forbion — partners on a couple…
    Endpoints · 2mo ago↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 2mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 2mo ago↗ source
  • Novartis RNA drug acquired in $12B Avidity deal notches a trial win
    The data showed that del-brax, an “antisense oligonucleotide conjugate” being tested against a muscle-wasting disease, met its primary endpoint in a Phase 1/2 study.
    BioPharma Dive · 2mo ago↗ source