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1,206 stories matching this filter · ← front page

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  • Angitia halts Phase 3 trial of AGA111 for degenerative disc disease
    Angitia Biopharmaceuticals announced that it has ended the Phase 3 study of its investigational therapy AGA111 in patients with degenerative disc disease who had undergone lumbar interbody fusion.…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Merck ends Phase 2 trial of Alzheimer’s drug MK-1167 from partner Neuphoria
    Merck announced it has terminated a mid-stage Phase 2 study of an experimental Alzheimer’s therapy. The drug, called MK-1167, is an oral candidate that was being developed in collaboration with bi…
    Endpoints · 1mo agoNegative↗ source
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Psychiatry & CNS729
Ophthalmology425
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Infectious Disease367
  • WuXi AppTec seeks court order to remove itself from U.S. Pentagon's Chinese military-linked company list
    WuXi AppTec has filed a petition for a preliminary injunction to halt its inclusion on the Pentagon's list of firms with alleged ties to the Chinese military. The company says the designation is d…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Ipsen to acquire Memo Therapeutics and its kidney infection candidate
    French drugmaker Ipsen announced a new acquisition, agreeing to buy Memo Therapeutics along with its experimental kidney infection drug. This marks Ipsen's second transaction announced within a wee…
    Endpoints · 1mo agoDealPositive↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • 92Bio revives experimental T cell engager previously handed to Amgen
    92Bio, a small California biotech, announced it is bringing back an experimental T‑cell engager it originally created before transferring the program to Amgen. The company said the candidate will…
    Endpoints · 1mo agoNeutral↗ source
  • Kao USA issues voluntary recall of select Oribe scalp shampoo lots over bacterial contamination
    Kao USA announced a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo in the United States and Canada after detecting the bacterium Pluralibacter gergoviae. The recall a…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Eunha Fisheries recalls frozen halibut and flounder sashimi after undisclosed wheat, soy, sesame found in condiment packets
    On July 1, 2026, Eunha Fisheries Co., Ltd. of Busan, South Korea announced a recall of certain sliced Korean halibut and flounder sashimi products. The recall covers items that were sold in the Uni…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • FDA picks seven firms, including Eli Lilly and Fujifilm, for PreCheck pilot to speed factory inspections
    The FDA announced that it has selected seven companies to join the inaugural PreCheck pilot, a program designed to accelerate the review of manufacturing facilities. The cohort includes large drug…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • AbbVie and Genmab's Epkinly shows positive combo results, moving toward label expansion in DLBCL
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a successful outcome when tested together with a commonly used cancer therapy. The data indicate that the combination was…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • FDA reviewers recommend against adding seven peptides to bulk drug list for compounding
    FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Abivax reports ulcerative colitis trial cancer rates align with expectations
    Abivax released new data from its Phase 3 trial of an ulcerative colitis candidate. The data show that the number of cancer cases observed was within the range normally expected for ulcerative col…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Anthropic launches Claude Science, AI platform aimed at bioscience and drug discovery
    Anthropic, known for its Claude Code AI coding assistant, announced a new product called Claude Science aimed at the life‑science sector. The platform is designed to help biopharma researchers wit…
    Endpoints · 1mo agoPositive↗ 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
  • Health AI caution crosses into confidence
    How people in health tech feel about AI in healthcare has changed drastically from just a year ago. Each year, health tech venture firm Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan…
    Endpoints · 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
  • FDA's acting director of cell and gene therapies to leave position
    Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday. Kumar…
    Endpoints · 1mo ago↗ source
  • Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO
    Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon-skipping drugs by end of February: The…
    Endpoints · 1mo ago↗ source
  • Beeline ups its Series A round for immune drug work
    The company, which was built by Bain Capital, has now raised more than $426 million in its quest to advance a portfolio of Bristol Myers drugs.
    BioPharma Dive · 1mo ago↗ source
  • Top FDA gene and cell therapy regulator to step down
    Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.
    BioPharma Dive · 1mo ago↗ source
  • Nominations are open for the 2026 Endpoints 11 awards
    There’s never been a higher bar for innovation than right now. Almost any promising molecule quickly has a horde of copycats. Development costs keep rising. Investors are leaning on seemingly safer…
    Endpoints · 1mo ago↗ source
  • How mental health chatbots are trained on therapy sessions
    As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay compe…
    Endpoints · 1mo ago↗ source
  • Unicycive gets second CRL for kidney drug as manufacturing woes continue
    Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxyl…
    Endpoints · 1mo ago↗ source
  • Sanofi’s Lumizyme successor passes Phase 3 test in babies with Pompe disease
    Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US. The French pharma is looking to…
    Endpoints · 1mo ago↗ source