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  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 13h agoNeutral↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 13h agoNeutral↗ source
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Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
fda medwatch · 1d ago↗ source
  • Recon: BMS plans $2.3B Houston manufacturing site; MHRA approves Lilly weight-loss drug for weight loss, type 2 diabetes
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Asia-Pacific Roundup: India establishes tougher penalties for filing misleading or fake documents
    The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.
    raps · 1d ago↗ source
  • FDA warns firm in India for falsified logbooks; two other companies warned for lax testing
    The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified logbooks to the agency. The agency also warned two other…
    raps · 1d ago↗ source
  • IMDRF details key principles for regulators to adopt PCCPs
    The International Medical Device Regulators Forum (IMDRF) has finalized a technical document outlining how regulatory agencies may adopt predetermined change control plans (PCCP). The document list…
    raps · 1d ago↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 4d agoRegulatoryNeutral↗ source
  • EMA releases updated guidance on drug shortage prevention plans
    The European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…
    raps · 4d agoRegulatoryNeutral↗ source
  • Senior staff purchase company shares, filing 16/2026 shows insider buying
    The company released a corporate announcement stating that several senior employees have bought shares of the firm. The filing, identified as 16/2026, does not provide details on the number of sha…
    globenewswire health · 3d agoNeutral↗ source
  • Company issues corporate announcement on senior employee transaction
    The company released a corporate announcement identified as item 18/2026. The notice indicates that a transaction involving a leading employee has taken place. No further details about the nature…
    globenewswire health · 3d agoNeutral↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 5d agoApprovalPositive↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 5d agoRegulatoryNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi buys 321,423 shares, raising his stake to 4.79 million
    Tiziana Life Sciences announced that its chief executive, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The transaction brings Elrifi’s total ownership…
    globenewswire health · 4d agoDealPositive↗ source
  • Novo Nordisk reports board and executive share transactions under EU market abuse rules
    On August 6, 2026 Novo Nordisk issued a company announcement detailing share transactions made by members of its board, senior executives and their close associates in line with Article 19 of EU Re…
    globenewswire health · 4d agoRegulatoryNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi boosts stake, buying 321,423 shares at $1 each
    Tiziana Life Sciences announced that its chief executive officer, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The purchase raises his total holding to…
    globenewswire health · 4d agoDealPositive↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 5d agoRegulatoryNeutral↗ source
  • Novo Nordisk board members disclose share vesting transactions
    Novo Nordisk issued a regulatory announcement on 6 August 2026 detailing share transactions by its board members, executives and related persons, as required by EU market abuse regulation. The fil…
    globenewswire health · 4d agoRegulatoryNeutral↗ source
  • InstallatørGruppen reports insider share transaction involving board members' associate
    InstallatørGruppen A/S has filed a Market Abuse Regulation (EU) No. 596/2014 notification under article 19, disclosing a recent share transaction. The transaction was executed by Absalon Holdings…
    globenewswire health · 4d agoRegulatoryNeutral↗ source
  • InstallatørGruppen reports share transaction by board linked entity Absalon Holdings
    InstallatørGruppen A/S filed a notification under the EU Market Abuse Regulation, article 19, to disclose a share transaction involving a person discharging managerial responsibilities and their cl…
    globenewswire health · 4d agoRegulatoryNeutral↗ source
  • AL Sydbank discloses share transactions by managers and related persons under MAR
    AL Sydbank issued a company announcement (No 41/2026) on 5 August 2026, informing the market of share transactions carried out by its managers and persons closely associated with them. The disclos…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
  • Danske Bank corrects placement of English PDF in transaction disclosure
    The bank originally posted a notice that attached both the Danish and English PDF files to the Danish version of its website. A correction has now moved the English PDF to the English version of th…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
  • Danske Bank corrects website link, moves English PDF to English page for shareholding report
    A correction notice was issued for Danske Bank A/S regarding the placement of an English PDF document on its website. The original announcement had both Danish and English PDFs attached under the…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
  • Danske Bank corrects website to place English PDF with share buyback filing
    Danske Bank issued a correction notice stating that the English version of a PDF document has been relocated on its website. The amendment moves the English PDF from the Danish page to the dedicat…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
  • AL Sydbank reports insider share transactions by senior staff and relatives
    AL Sydbank issued a market abuse regulation disclosure detailing share transactions by its senior employees and their close associates. The filing references attached tables that list the specific…
    globenewswire health · 5d agoNeutral↗ source