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  • Teva says it has time to prepare for upcoming US tariffs on imported generic drugs
    Teva CEO Richard Francis said the company believes it has sufficient time to prepare for the tariffs the Trump administration is considering on generic drugs imported from outside the United States…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 2d agoDealNeutral↗ source
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  • Two biotech firms announce reverse mergers to list experimental bispecific antibody and BTK inhibitor on Nasdaq
    Two biotech companies have each entered reverse merger agreements to become publicly traded on Nasdaq. One firm, based in China, is developing a bispecific antibody and will use the merger to brin…
    Endpoints · 2d agoDealNeutral↗ source
  • AI startup Doctronic acquires text-message pediatric care provider Summer Health
    Doctronic, a startup that markets itself as an AI doctor, announced it has purchased Summer Health, a company that offers pediatric care via text messaging. The acquisition expands Doctronic’s ser…
    Endpoints · 2d agoDealNeutral↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 3d agoRegulatoryNegative↗ source
  • Former Recursion CEO Chris Gibson joins Dimension Capital as operating partner
    Chris Gibson, who led Recursion Pharmaceuticals for a decade, has taken a new role at venture firm Dimension Capital. At Dimension, he will serve as an operating partner, bringing his experience a…
    Endpoints · 2d agoPositive↗ source
  • NYU's Neil Vasan steps down as acting chair of FDA's oncology drug advisory committee
    Neil Vasan, a professor at NYU, has announced he is stepping down from his role as acting chair of the FDA’s Oncologic Drugs Advisory Committee (ODAC). Vasan has participated in 22 ODAC meetings a…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • Publix recalls all GreenWise Organic frozen blueberries and mixed berries over potential E. coli O145 contamination
    Publix announced a recall of all lots of GreenWise Organic Whole Blueberries and Whole Mixed Berries because the products may be contaminated with Escherichia coli O145:H28. The strain is a Shiga…
    fda recalls · 3d agoCRLNegative↗ source
  • FDA warns investors that advisory panel reviews do not guarantee drug approval, cites concerns at Capricor and Replimune
    The FDA issued a reminder to investors that the outcomes of advisory committee meetings are not final decisions on a drug’s fate. This week the agency released briefing documents highlighting conc…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • J&J offers $5.5 billion settlement to resolve talc lawsuits
    Johnson & Johnson has put forward a settlement proposal of $5.5 billion to end the litigation over its talc products. The proposal follows more than a decade of legal battles and three unsuccessfu…
    Endpoints · 3d agoDealNeutral↗ source
  • FDA updates guidance for generic makers of top GLP-1 weight-loss drugs
    The FDA has released a revised draft guidance aimed at companies that want to develop generic versions of leading weight-loss medications. The update focuses on products such as Eli Lilly's Zepbou…
    Endpoints · 3d agoRegulatoryNeutral↗ 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 · 3d agoDealPositive↗ source
  • GSK announces $2.5 billion annual cost-cutting plan to offset upcoming patent cliff
    GSK disclosed in its latest quarterly earnings that it will launch a three-year restructuring aimed at saving about £1.9 billion ($2.5 billion) each year. The plan is intended to cushion the impac…
    BioPharma Dive · 3d agoLayoffsNeutral↗ source
  • Oak Hill Bio to merge with RA Capital SPAC as InnoCare’s TYK2 candidate reports positive Phase 3 results
    Oak Hill Bio, a biotech focused on Angelman syndrome, announced it will combine with RA Capital’s special purpose acquisition company, Research Alliance Corporation III. The transaction will give O…
    Endpoints · 3d agoDealPositive↗ source
  • FDA staff say Replimune's melanoma trial fails to demonstrate efficacy
    FDA staff reviewing Replimune's pivotal melanoma study concluded that the trial design did not provide sufficient evidence that the RP1 therapy works. The assessment was issued ahead of a schedule…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • Alnylam shares tumble 30% even as biotech sector rallies
    Alnylam's stock fell about 30% on July 28, 2026, even though the broader biotech market is experiencing a resurgence. The market rebound follows years of a bearish environment, with increased merg…
    Endpoints · 3d agoNegative↗ source
  • Mirae secures $5.4 million to convert patient chatbot messages into clinical data
    Mirae, a health‑tech startup, announced it has closed a financing round that brought in $5.4 million. The capital will be used to develop its chatbot platform that encourages patients to describe…
    Endpoints · 3d 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 · 3d agoDealPositive↗ source
  • FDA’s AI push faces uncertainty after key leaders depart
    The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
    BioPharma Dive · 3d agoRegulatoryNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA advisory panel debates allowing compounding pharmacies to produce seven peptides
    The FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 4d agoRegulatoryNeutral↗ source
  • Updated: GSK reveals three-year blueprint to cut costs and propel R&D
    Just a little over six months into his tenure as CEO at GSK, Luke Miels is making his mark. The drugmaker on Tuesday outlined plans for a three-year cost-cutting initiative, the launch of at least ...
    Endpoints · 3d agoNeutral↗ source
  • Updated: Altimmune’s GLP-1-based shot cuts drinking in patients with alcoholism
    Altimmune said Tuesday that its GLP-1/glucagon agonist reduced drinking in people with moderate-to-severe alcohol use disorder in a mid-stage study. Patients in the Phase 2 RECLAIM trial took a wee…
    Endpoints · 3d agoNeutral↗ source