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376 stories matching this filter · ← front page

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  • 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 · 16d 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 · 16d agoRegulatoryNeutral↗ source
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  • 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 · 16d 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 · 16d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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 · 15d agoRegulatoryNeutral↗ 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d agoCRLNegative↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 17d agoRegulatoryNeutral↗ source
  • Leo International Precision Health AG issues 3.77 million free shares to PC Beteiligungsgesellschaft mbH after capital increase
    Leo International Precision Health AG announced that its shareholder meeting on June 12, 2026 approved a capital increase funded from company reserves. As a result, the company will allocate 3,772…
    globenewswire health · 17d agoNeutral↗ source
  • Leo International Precision Health issues 3.77 million free shares to PC Beteiligungsgesellschaft after capital increase
    Leo International Precision Health AG announced that it will allocate 3,772,368 newly issued free shares to PC Beteiligungsgesellschaft mbH. The allocation follows a capital increase approved by t…
    globenewswire health · 17d agoDealNeutral↗ source
  • Leo International Precision Health allocates 78.8 million bonus shares to board member Leo Wang
    Leo International Precision Health AG announced that Mr Leo Wang will receive an allocation of 78,844,000 bonus shares. The shares are issued from the company’s own funds as part of a capital incre…
    globenewswire health · 17d agoNeutral↗ source
  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft
    Leo International Precision Health AG announced that PC Beteiligungsgesellschaft mbH will receive 3,772,368 bonus shares. The allocation stems from a capital increase funded by the company’s own r…
    globenewswire health · 17d agoNeutral↗ source
  • Leo International Precision Health AG grants 78.8 million free shares to board member Leo Wang after capital increase
    Leo International Precision Health AG announced that Mr. Leo Wang, a member of its supervisory board, will receive 78,844,000 free shares. The allocation stems from a capital increase approved by…
    globenewswire health · 17d agoNeutral↗ source