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  • KKR to acquire medtech maker Integer in $5.7 billion deal
    KKR announced an agreement to take Integer private for approximately $5.7 billion, offering $127 per share in cash to Integer stockholders. Integer, based in Plano, Texas, saw its shares rise abou…
    Fierce Biotech · 17d agoDealNeutral↗ source
  • Latigo Biotherapeutics targets non-opioid pain market with $247 M IPO
    Latigo Biotherapeutics announced details of its planned initial public offering, aiming to raise roughly $247 million to advance its pipeline of non-opioid pain treatments. The company intends to…
    Fierce Biotech · 17d agoDealPositive↗ source
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  • Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
    BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
    fda medwatch · 17d agoRegulatoryNeutral↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 17d agoRegulatoryNeutral↗ source
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 17d agoCRLNegative↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports share sale by APMH Invest under its buyback program
    On August 4, 2026, Danske Bank A/S filed a market‑abuse regulation report detailing a change in share ownership. The filing shows that APMH Invest A/S sold a portion of its Danske Bank shares on a…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank discloses managerial transactions per Danish regulator on Aug 4, 2026
    Danske Bank A/S issued a notification on 4 August 2026 regarding transactions made by individuals who hold managerial responsibilities. The disclosure follows the EU Market Abuse Regulation, requi…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports ongoing share buy-back related sales by APMH Invest
    Danske Bank A/S filed a notification on 4 August 2026 concerning transactions made by persons with managerial responsibilities. The filing, identified as notification no. 61/2026, complies with th…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports ongoing share buy-back and manager-related share sales
    Danske Bank A/S disclosed that, as part of its share repurchase programme, APMH Invest A/S is continuously selling shares on a proportional basis. The filing notes that the transactions are made b…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank files mandatory disclosure of manager transactions under EU market abuse rules
    Danske Bank A/S submitted a notification on 4 August 2026 detailing transactions made by individuals with managerial responsibilities, as required by the Danish Financial Supervisory Authority and…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports share sale by APMH Invest under its buyback program
    On August 4, 2026 Danske Bank A/S filed a regulatory disclosure detailing a change in share ownership among its reporting parties, as required by the EU market abuse regulation. The filing states…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank reports changes in shareholdings of senior staff on Aug 4, 2026
    Danske Bank A/S filed a market abuse regulation report on 4 August 2026 that records changes in share ownership by senior employees and persons closely linked to them. The filing, identified as re…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Danske Bank files EU market-abuse disclosure of senior staff share transactions
    Danske Bank submitted a filing on 4 August 2026 reporting changes in shareholdings by its senior employees in line with the EU market-abuse regulation. The report lists transactions carried out by…
    globenewswire health · 17d agoRegulatoryNeutral↗ source
  • Curium to acquire Lantheus in deal valued up to $8 billion
    Curium announced it will purchase all outstanding shares of Lantheus for $102.50 cash per share, with potential additional $12 per share via contingent value rights linked to sales milestones in pr…
    Fierce Biotech · 18d agoDealNeutral↗ source
  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 18d agoDealNegative↗ source
  • BlossomHill Therapeutics targets $112 million IPO to fund EGFR lung-cancer drug BH-30643
    BlossomHill Therapeutics, a San Diego oncology biotech, announced plans for an initial public offering to raise about $112 million. The company intends to sell 7.8 million shares at $15-$17 each,…
    Fierce Biotech · 18d agoDealPositive↗ source
  • BD recalls specific lots of intraosseous needle sets over obturator removal issues
    BD announced a voluntary recall of certain lots of its intraosseous vascular access system needle sets after users reported difficulty removing the obturator after placement. The issue is linked t…
    fda medwatch · 18d agoCRLNegative↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 18d agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 18d agoCRLNegative↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 18d agoRegulatoryNeutral↗ source
  • Medline orders correction of convenience kits containing lidocaine and bupivacaine in dextrose injection
    Medline has issued a correction for certain convenience kits that include lidocaine hydrochloride and bupivacaine hydrochloride mixed with dextrose injection. The FDA has classified this recall as…
    fda medwatch · 18d agoCRLNegative↗ source
  • American Regent recalls two lots of Adequan canine injection and two lots of Adequan i.m. for horses due to glass fibers
    American Regent Animal Health announced a nationwide recall of specific lots of its Adequan products for dogs and horses. The recall includes two lots of the 100 mg/mL 5 mL multi‑dose canine injec…
    fda medwatch · 18d agoCRLNegative↗ source